L. Paracasei by Custom Probiotics

POSSIBLY EFFECTIVE

• Allergic rhinitis (hay fever). Oral live or heat-killed Lacticaseibacillus paracasei seems to improve some symptoms of allergic rhinitis in adults and children. Details: Clinical research in adults with persistent allergic rhinitis due to grass pollen despite treatment with loratadine shows that taking L. paracasei LP-33 as 2 billion colony-forming units (CFUs) daily for 5 weeks can improve quality of life by almost 18% when compared with placebo. The improvement in quality of life appears to be related to improvements in eye-related symptoms, but not nasal symptoms (90242). In children with perennial allergic rhinitis due to dust mites, taking L. paracasei LP-33 10 billion CFUs daily for 30 days improves quality of life related to overall symptom severity or level of bother by 28% and 23%, respectively, when compared to placebo. However, quality of life related specifically to nasal and eye-related symptoms was not improved when compared with placebo (107532). In children ages 2-5 years with allergic rhinitis, clinical research shows that taking fermented milk (Danone) containing L. paracasei DN-114 011 10 billion CFUs daily does not increase the time free from rhinitis episodes, the mean duration of episodes, or the cumulative number of episodes, when compared with taking a control milk. However, the number of episodes was reduced between months 3-9. The fermented milk was made with the yogurt cultures Lactobacillus delbrueckii subsp. bulgaricus and Streptococcus thermophilus (112512). Heat-killed L. paracasei has also been investigated. One clinical trial in adults with chronic allergy symptoms shows that taking heat-killed L. paracasei IJH-SONE68 1040 mg or 500,000 cells daily for 12 weeks modestly improves self-reported symptoms, including frequencies of sneezing and blowing, watery eyes, and head dullness, when compared with taking placebo. There was no effect on nasal congestion or itchy eyes (111939). Also, clinical research in children aged 5 years and older with perennial allergic rhinitis due to dust mites shows that taking heat-killed L. paracasei LP-33 10 billion cells daily for 30 days improves quality of life related to overall symptom severity or level of bother by 18% and 22%, respectively, when compared with placebo. Efficacy was not inferior to live L. paracasei LP-33 (107532).
• Atopic dermatitis (eczema). Oral live Lacticaseibacillus paracasei, alone or in combination with other probiotics, seems to be beneficial for the treatment of atopic dermatitis in infants and children and for preventing atopic dermatitis when provided to the infant after exposure during pregnancy. Small clinical trials suggest that heat-killed L. paracasei does not seem to be beneficial for the treatment of atopic dermatitis. Details: In children aged 1-18 years, clinical research shows that taking L. paracasei 2 billion colony-forming units (CFUs) daily, alone or with Limosilactobacillus fermentum 2 billion colony-forming units (CFUs) daily each, for 3 months modestly reduces symptoms of atopic dermatitis when compared with placebo (98440). However, another clinical trial shows that administering formula containing lyophilized L. paracasei CNCM I-2116 to infants aged 3-6 months does not reduce atopic dermatitis severity or the prevalence of atopic dermatitis after 12 weeks of treatment (90256). Heat-killed L. paracasei has also been investigated. In adults treated with conventional topical corticosteroid and tacrolimus, a small clinical trial shows that taking heat-killed L. paracasei K71 200 billion cells daily for 12 weeks does not improve skin symptom severity, quality of life, or use of topical medication, when compared with taking placebo (111947). Also, in infants ages 4-30 months with atopic dermatitis, clinical research shows that, in addition to topical fluticasone propionate cream, taking heat-treated L. paracasei GM-080 daily for 16 weeks does not further improve symptoms when compared with using the topical fluticasone propionate cream alone (102406). Other clinical research has investigated the effects of L. paracasei in combination with other probiotics for the PREVENTION of atopic dermatitis. A combination of L. paracasei, Ligilactobacillus salivarius, Bifidobacterium animalis subsp. lactis, and Bifidobacterium bifidum, a total of 10 billion CFUs daily provided from 36 weeks' gestation and then to the infant until age 6 months, reduces the prevalence of atopic dermatitis at age two by approximately 60% (90234). Similar findings occurred in clinical research investigating the effect of L. paracasei ST11 and B. longum BL999 (ST11+BL999) for the last 2 months of pregnancy and first 2 months of breastfeeding (90234,90285).
• Common cold. A combination of Lacticaseibacillus paracasei and Lactiplantibacillus plantarum seems to be beneficial for reducing the incidence or severity of the common cold. The effects of L. paracasei alone are unclear. Details: Clinical research in healthy individuals shows that taking an acidified milk drink providing L. paracasei (L. casei 431) 1 billion colony-forming units (CFUs) daily for 21 days before and after receiving the seasonal influenza vaccination does not affect the number, duration, or severity of common cold or influenza-like illness episodes when compared with taking placebo. However, there was a modest reduction in the duration of illness 4-6 weeks after vaccination (111937). L. paracasei has also been examined in combination with L. plantarum. Clinical research shows that taking L. plantarum HEAL 9 (DSM 15312) and L. paracasei 8700:2 (DSM 13434) (Probi Defendum, Probi AB) 1 billion CFUs daily for 12 weeks reduces the incidence of the common cold by about 12% and reduces the number of symptomatic days from 8.6 to 6.2 when compared with placebo (17119). Additional clinical research in adults at increased risk of a common cold shows that taking this same combination for 12 weeks does not reduce the incidence of developing a common cold when compared with placebo. However, symptom severity was modestly reduced. Also, each episode was reduced by an average of 1.1 days (107557). A more recent clinical study in adults at increased risk of developing a common cold shows that taking the same combination does not reduce symptom severity or the absolute number of common cold episodes when compared with placebo. However, in individuals with at least one cold, the mean number of colds was reduced by 0.12 over the 12-week period. In addition, there were modest overall reductions in the incidence of recurring colds and the use of analgesics (107555). A smaller clinical trial using the same product at the same dose and duration has also been conducted in children aged 1-6 years in daycare. The severity of nasal congestion/runny nose was modestly reduced when compared with placebo in this population. However, there were no differences between groups in the overall incidence, severity, or duration of common colds or upper respiratory tract infections or the number of days absent from daycare (107556). This latter trial was terminated prior to the completion of the planned patient recruitment for reasons unrelated to adverse effects, which may have impacted the findings. L. paracasei has also been investigated as part of fermented milk. A clinical trial in elderly nursing home residents shows that drinking two bottles of fermented milk containing L. paracasei Shirota daily for 6 months does not reduce the risk of developing respiratory symptoms when compared with placebo milk (96885). However, a small clinical study in healthy, male, middle-aged office workers shows that drinking a fermented milk made with L. paracasei Shirota for 12 weeks reduces the incidence and duration of the common cold by 59% when compared with a control milk (98426). Also, a clinical study in children aged 3-6 years attending daycare shows that drinking a fermented milk product containing L. paracasei (Actimel, Danone) 200 grams daily for 3 months reduces the risk of developing the common cold, the most common upper respiratory tract infection in these children, by around 18% when compared with a control milk product. The fermented milk product did not affect medication use or sick leave from daycare (96882).

POSSIBLY INEFFECTIVE

• Constipation. Oral Lacticaseibacillus paracasei does not seem to be beneficial for constipation. Details: Meta-analyses of two or three clinical trials in adults with functional constipation show that taking L. paracasei Shirota 6.5-30 billion colony-forming units daily for 4 weeks does not appear to improve gut transit time or increase the number of stools (95342). Also, clinical research in patients with constipation shows that taking a combination of L. paracasei Lpc-37 2.5 billion colony-forming units daily for 2 weeks along with Lactobacillus acidophilus NCFM and Bifidobacterium animalis subsp. lactis strains Bl-04, Bi-07, and HN019, does not improve bloating, abdominal pain, intestinal transit time, frequency of bowel movements, or stool consistency when compared with placebo. There was a small beneficial effect on flatulence (110979).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Acne. It is unclear if topical heat-killed Lacticaseibacillus paracasei is beneficial for acne. Details: Preliminary clinical research in patients with mild to moderate acne shows that topical application with a lotion providing the cell-free supernatant of L. paracasei MSMC 39-1 twice daily for 4 weeks is as effective as a lotion containing 2.5% benzoyl peroxide for decreasing redness and the inflammatory acne lesion count. There was no effect of either lotion of non-inflammatory acne lesion count (111945). This study is limited by the lack of blinding to lotion type.
• Alcohol-related liver disease. It is unclear if oral Lacticaseibacillus paracasei is beneficial in patients with alcohol-related liver disease. Details: Clinical research in patients with alcohol-related liver disease shows that taking fermented milk providing L. paracasei Shirota daily for 60 days reduces levels of triglycerides and low-density lipoprotein (LDL) cholesterol by 27% and 24%, respectively, compared with taking placebo. There was also an improvement in liver function, based on modest improvements in various liver markers, including alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase, and bilirubin. Patients consumed L. paracasei 20 billion colony-forming units daily (111958).
• Antibiotic-associated diarrhea. It is unclear if oral Lacticaseibacillus paracasei is beneficial for preventing antibiotic-induced diarrhea. Details: Most clinical research has investigated the effect of L. paracasei in combination with other probiotics. A meta-analysis of 3 clinical trials in hospitalized or outpatient adults shows that taking L. paracasei in combination with up to 8 other probiotic strains reduces the risk of AAD by 40% when compared with taking placebo (107635). One of these studies, a small clinical trial in patients taking amoxicillin 500 mg twice daily for 7 days, used a specific combination probiotic (Ecologic AAD) twice daily for 14 days. The product provided L. paracasei NIZO 3672, Bifidobacterium bifidum NIZO 3804, Bifidobacterium animalis subsp. lactis NIZO 3680, Enterococcus faecium NIZO 3886, Lactobacillus acidophilus NIZO 3678 and NIZO 3887, Lactiplantibacillus plantarum NIZO 3684, Lacticaseibacillus rhamnosus NIZO 3689, and Ligilactobacillus salivarius NIZO 3675 as 1 billion colony-forming units (CFUs) each daily (95405). In addition, one small clinical study in hospitalized adults shows that consuming a 97 mL drink (Actimel, Danone) containing L. paracasei 100 CFUs/mL, Streptococcus thermophilus 100 million CFUs/mL, and Lactobacillus delbrueckii subsp. bulgaricus 10 million CFUs/mL twice daily while taking antibiotics reduces the odds of developing AAD by 75% when compared with a milkshake without probiotics (16740). However, an additional large clinical trial in children aged 3 months and up shows that taking L. paracasei in combination with other probiotics does not reduce the risk of antibiotic-associated diarrhea when compared with taking placebo, when the more stringent definition is considered excluding diarrhea of other etiologies. However, the risk of diarrhea of any etiology is reduced by 35%. The probiotic supplement provided a total of 10 billion CFUs of L. paracasei W20, Lactobacillus acidophilus W37, Lactobacillus acidophilus W55, Bifidobacterium bifidum W23, Bifidobacterium animalis subsp. lactis W51, Lactiplantibacillus plantarum W62, Lacticaseibacillus rhamnosus W71, and Ligilactobacillus salivarius W24 daily from the first day of antibiotic treatment until 7 days after treatment ended (110969). It is unclear if any benefits are due to L. paracasei, the other ingredients, or their combination. L. paracasei has also been investigated alone. In hospitalized patients with spinal cord injury, preliminary clinical research shows that 17.1% of patients taking L. paracasei Shirota 6.5 billion CFUs daily in a probiotic drink (Yakult light) developed diarrhea compared with 54.9% of those given only routine care. L. paracasei was taken during antibiotic treatment and for an additional 7 days (111955). This study is limited by a lack of blinding.
• Antituberculosis treatment-associated adverse effects. It is unclear if oral Lacticaseibacillus paracasei is beneficial for preventing adverse effects associated with antituberculosis treatment. Details: Preliminary clinical research shows that taking L. paracasei Shirota 10 billion or 20 billion colony-forming units (CFUs) daily during standard antituberculosis treatment does not reduce the incidence of liver injury when compared with antituberculosis treatment alone. However, there was a modest decrease in the incidence of elevated alkaline phosphatase in patients taking 20 billion CFUs daily and a modest decrease in the incidence of elevated bilirubin in patients taking 10 billion CFUs daily. There was no effect on other liver markers (107509). Other preliminary clinical research shows that taking this same dose daily for 2 months during standard antituberculosis treatment reduces the rate of any gastrointestinal adverse event to 29% to 38% of patients, compared with 50% of those taking antituberculosis treatment alone. In addition, the duration of symptoms was shorter. However, when individual gastrointestinal adverse events were evaluated, only the incidence and duration of vomiting and appetite loss were reduced; the incidence of nausea, diarrhea, flatulence, and constipation were unaffected (107542).
• Asthenopia (eye strain). It is unclear if oral heat-killed Lacticaseibacillus paracasei is beneficial for asthenopia. Details: Preliminary clinical research shows that taking heat-killed L. paracasei 50 mg daily for 8 weeks does not decrease eye fatigue induced by blue-light emitting devices when compared with placebo. However, a subgroup analysis shows that in patients who report eye fatigue at baseline, subjective symptoms of eye fatigue and eye redness are reduced after exposure to blue-light emitting devices (98429).
• Asthma. It is unclear if oral Lacticaseibacillus paracasei is beneficial for asthma. Details: A small clinical study in children with asthma shows that taking L. paracasei GMNL-133 (LP) 2 billion colony-forming units (CFUs), Limosilactobacillus fermentum GM-090 (LF) 2 billion CFUs, or both strains together daily for 3 months seems to modestly reduce asthma severity and increase Childhood Asthma Control Test (C-ACT) scores when compared with placebo (99785). In children ages 2-5 years with asthma, clinical research shows that taking fermented milk (Danone) containing L. paracasei DN-114 011 10 billion colony-forming units daily does not increase the time free from asthma episodes, the mean duration of episodes, or the cumulative number of episodes, when compared with taking a control milk. The fermented milk was made with the yogurt cultures Lactobacillus delbrueckii subsp. bulgaricus and Streptococcus thermophilus (112512).
• Cancer. Although there has been interest in using oral Lacticaseibacillus paracasei for cancer prevention or treatment, there is insufficient reliable information about the clinical effects of L. paracasei for this condition.
• Canker sores. Oral Lacticaseibacillus paracasei has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical trial shows that taking a combination of L. paracasei, Lacticaseibacillus rhamnosus, Lactobacillus acidophilus, and Bifidobacterium animalis subsp. lactis modestly reduces pain, but not the number of lesions or healing time, when compared with placebo (107548).
• Clostridioides difficile infection. Although there has been interest in using oral Lacticaseibacillus paracasei for C. difficile infection prevention, there is insufficient reliable information about the clinical effects of L. paracasei for this condition.
• Colic. Although there has been interest in using oral Lacticaseibacillus paracasei for colic, there is insufficient reliable information about the clinical effects of L. paracasei for this condition.
• Colorectal cancer. It is unclear if oral Lacticaseibacillus paracasei is beneficial for colorectal cancer prevention. Details: Clinical research in patients with previous removal of colorectal tumors shows that taking at least 1.5 billion colony-forming units L. paracasei Shirota 3 times daily for 4 years does not prevent the development of new colorectal tumors when compared with not taking L. paracasei. However, taking L. paracasei reduces the occurrence of colorectal tumors with moderate or severe atypia by 35%. Half of the patients included in this research were also consuming wheat bran biscuits (111959).
• Dental caries. It is unclear if oral Lacticaseibacillus paracasei is beneficial for dental caries prevention. Details: Preliminary clinical research shows that giving infants a weaning cereal containing L. paracasei F19 (Semper AB) from 4 months of age until 13 months of age does not reduce the risk of dental caries in the primary or permanent teeth by the age of 3, 6, or 9 years (90260).
• Depression. Although there has been interest in using oral Lacticaseibacillus paracasei for depression, there is insufficient reliable information about the clinical effects of L. paracasei for this condition.
• Diabetes. Oral Lacticaseibacillus paracasei has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in patients with gestational diabetes shows that taking a specific product containing L. paracasei and other probiotics (Visbiome, ExeGi Pharma) as a total of 112.5 billion colony-forming units (CFUs) twice daily for 8 weeks does not affect levels of fasting blood glucose or glycated hemoglobin (HbA1c) when compared with placebo. However, there were small improvements in insulin levels and insulin resistance (107549). This same combination probiotic has also been evaluated in children 2-12 years of age with new-onset type 1 diabetes. One clinical study shows that taking Visbiome as 112.5 billion CFUs daily for 3 months modestly decreases HbA1c and insulin requirements when compared with placebo. Also, about three times as many children achieved remission, defined as insulin requirements of less than 0.5 U/kg daily and HbA1c of less than 7%. However, C-peptide levels and the maintenance of residual pancreatic beta-cell function were not affected when compared with placebo (107497).
• Diarrhea. It is unclear if oral Lacticaseibacillus paracasei is beneficial for the treatment of diarrhea. Details: While the European Society for Pediatric Infectious Diseases recommends probiotics in hospitalized children with diarrhea (98469) and the Infectious Disease Society of America (IDSA) recommends probiotics for the outpatient treatment of acute diarrhea (95388), both guidelines note that most evidence is low quality. Also, evidence related to the use of L. paracasei, specifically, is limited. One large clinical study shows that taking a fermented milk product containing L. paracasei DN-114 001 (e.g., DanActive, Dannon) 100 million CFUs per milliliter for up to 4 months helps to prevent acute, non-rotaviral diarrhea in children ages 6-24 months (14374).
• Exercise-induced muscle damage. It is unclear if oral Lacticaseibacillus paracasei is beneficial for exercise-induced muscle damage. Details: Clinical research in adults shows that taking L. paracasei L-PS23 20 billion colony-forming units or heat-killed L. paracasei HK-PS23 20 billion cells daily modestly reduces muscle strength loss and improves measures of muscle recovery in the 48 hours following exercise-induced muscle damage when compared with taking placebo. L. paracasei was taken for 6 weeks prior to inducing muscle damage and continued for an additional 48 hours (111940).
• Exercise-induced respiratory infections. It is unclear if oral Lacticaseibacillus paracasei is beneficial for preventing respiratory infections related to exercise. Details: Clinical research in endurance athletes shows that taking a probiotic supplement containing L. paracasei Shirota (LCS, Yakult) 65 billion colon-forming units (CFUs) twice daily for 20 weeks does not reduce the risk of developing an upper respiratory tract infection when compared with placebo. Taking this probiotic also does not reduce the duration or severity of respiratory infections in this population (98431). However, other clinical research shows that taking L. paracasei Shirota 6.5 billion CFUs daily for 4 months during winter endurance training modestly reduces the proportion of athletes with at least 1 week with upper respiratory tract illness symptoms by 27%, and the total number of episodes by 0.9, when compared with taking placebo. There was no difference in symptom severity or duration (111950).
• Fractures. It is unclear if oral Lacticaseibacillus paracasei is beneficial for the healing of fractures. Details: A clinical study in elderly adults with distal radius fracture shows that consuming 100 mL of skim milk containing L. paracasei Shirota 12 billion colony-forming units twice daily for 3 months modestly improves hand function, pain, and daily life activities when compared with skimmed milk placebo (102407). This study is limited by the fact that, although subjective measures showed improvement, there was no consistent improvement in objective measures.
• Helicobacter pylori. It is unclear if oral Lacticaseibacillus paracasei is beneficial in children with H. pylori infection. Details: Clinical research in H. pylori-colonized children aged 6 to 17 years shows that taking a fermented dairy product containing live or heat-killed L. paracasei ST11 (Chamyto, Nestle'-Chile SA, Santiago, Chile) 1.6 billion cells or colony-forming units 5 days each week for 4 weeks does not reduce H. pylori colonization when compared with the beverage without L. paracasei. The beverages were fermented with Lactobacillus helveticus (110934).
• HIV/AIDS. Although there has been interest in using oral Lacticaseibacillus paracasei for HIV/AIDS, there is insufficient reliable information about the clinical effects of L. paracasei for this condition.
• Hypercholesterolemia. It is unclear if oral Lacticaseibacillus paracasei is beneficial for hypercholesterolemia. Details: A small clinical trial in patients with hypercholesterolemia shows that taking 10.5 billion colony-forming units of L. paracasei TISTR 2593 daily for 90 days reduces levels of low-density lipoprotein cholesterol by about 11% when compared with taking placebo. There was no effect on total or high-density lipoprotein cholesterol or triglyceride levels (111938).
• Insomnia. It is unclear if oral Lacticaseibacillus paracasei is beneficial for improving sleep quality. Details: A small clinical trial in students shows that taking fermented milk containing L. paracasei Shirota daily for 11 weeks, starting 8 weeks prior to a stressful standardized examination, modestly reduces feelings of sleepiness upon rising and increases sleep length when compared with a non-fermented placebo milk. Objective measures of sleep latency were also reduced. There was no effect on total sleep time or sleep efficacy (111949).
• Irritable bowel syndrome (IBS). It is unclear if oral Lacticaseibacillus paracasei is beneficial for IBS. Details: One clinical study shows that taking a specific multi-species probiotic (Visbiome, ExeGi Pharma) containing L. paracasei and seven other probiotics as 450 billion colony-forming units (CFUs) daily in two divided doses for 8 weeks improves abdominal bloating, but not abdominal pain, flatulence, or number of stools, in patients with diarrhea-predominant IBS (IBS-D) (11379). However, adding this product as 900 billion CFUs daily to a sham diet or a low-FODMAP diet for 4 weeks does not improve IBS symptoms when compared with placebo (98741). Another clinical study in patients with IBS-D shows that taking a specific multi-species probiotic (NordBiotic, MBM Biotix) containing L. paracasei LPC100, Lacticaseibacillus rhamnosus LR110, Lactobacillus acidophilus LA120, Lacticaseibacillus casei LC130, and Lactiplantibacillus plantarum LP140, Bifidobacterium breve BB010, Bifidobacterium longum BL020, Bifidobacterium bifidum BF030, Bifidobacterium animalis subsp. lactis BL040, and Streptococcus thermophilus ST250 as 2.5 billion CFUs total twice daily for 8 weeks improves overall symptom severity, as well as pain severity, pain frequency, and quality of life when compared with placebo. Symptom severity was rated as mild by approximately 60% of those taking the probiotic mixture, compared with 30% of those taking placebo (107516). However, other clinical research shows that taking L. paracasei HA-196 10 billion CFUs daily or L. paracasei Shirota 13 billion CFUs daily for 8 weeks or a combination of L. paracasei, L. acidophilus, and B. animalis subsp. lactis BB-12 (Cultura) 13-20 billion CFUs daily for 6 months does not improve most symptoms of IBS (90236,94696,94697,103440,111952). L. paracasei has also been examined in combination with other ingredients. In patients 60 years and older with IBS, taking L. paracasei DKGF1 100 billion CFUs daily with Opuntia humifusa extract more than doubles the proportion of patients with improvements in self-reported overall symptoms during more than 2 of the 4 weeks of treatment when compared with taking placebo. Response rates for abdominal pain and psychological well-being were also improved. However, there were no differences between groups for response rates related to improvements in gas or bloating (111943).
• Japanese cedar pollinosis. It is unclear if oral Lacticaseibacillus paracasei is beneficial for Japanese cedar pollinosis. Details: Clinical research in patients with Japanese cedar pollinosis shows that taking L. paracasei KW3110 at least one trillion colony-forming units daily for 12 weeks starting 1 month before the start of the pollen season does not improve nasal symptoms during peak season when compared with taking placebo (111948).
• Lower respiratory tract infections. Oral Lacticaseibacillus paracasei has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in children ages 3-6 years shows that taking taking fermented milk (DanActive, Dannon) containing L. paracasei DN-114 011 20 billion colony-forming units daily for 90 days does not prevent lower respiratory tract infections when compared with taking a control non-fermented milk. The fermented milk was made with the yogurt cultures Lactobacillus delbrueckii subsp. bulgaricus and Streptococcus thermophilus (112515).
• Lyme disease. Although there has been interest in using oral Lacticaseibacillus paracasei for Lyme disease, there is insufficient reliable information about the clinical effects of L. paracasei for this condition.
• Migraine headache. It is unclear if oral Lacticaseibacillus paracasei is beneficial for migraine treatment. Details: Clinical research in patients with moderate to severe vestibular symptoms associated with migraine headaches shows that taking L. paracasei Shirota 20 billion colony-forming units daily for 4 months modestly reduces symptoms of vertigo and dizziness. The number of attacks with vertigo each week was reduced by 1.6, compared with 0.9 in patients taking placebo. Both vertigo and dizziness severity, as well as feelings of anxiety and depression, were also modestly reduced (111951). Although changes in these endpoints were statistically significant after 4 months, there were no differences between endpoints after 2 months, and the clinical significance is unclear.
• Necrotizing enterocolitis (NEC). It is unclear if oral Lacticaseibacillus paracasei is beneficial or safe for NEC prevention. Details: Most meta-analyses of clinical research show that giving lactobacilli enterally reduces the risk of NEC and/or severe NEC in preterm, mainly very low birth weight (VLBW), infants. Some meta-analyses support the use of lactobacilli in combination with bifidobacteria, as opposed to lactobacilli alone for reducing the risk of NEC. However, the effects of L. paracasei, specifically, are unclear (95344,95351,103437,103445,104157,105162,105164). Also, guidance among regulatory agencies and clinical organizations varies with respect to the use of probiotics in very low birth weight infants under 1000 grams. The US Food and Drug Administration (FDA) warns that preterm infants given probiotics are at risk of serious infections caused by the bacteria or fungi contained in probiotics due to cases reported in this group of infants (111610). Also, The American Academy of Pediatrics does not support the routine administration of probiotics to preterm infants, particularly those with a birth weight below 1000 grams, due to conflicting data on safety and efficacy and potential for harm in this vulnerable population (111608). The Canadian Paediatric Society, the American Gastroenterological Association, and the European Society for Paediatric Gastroenterology, Hepatology and Nutrition state that probiotic combinations may be of benefit in reducing the incidence of NEC in preterm neonates over 1000 grams. However, L. paracasei is not specifically recommended (103003,111609,111611).
• Nonalcoholic fatty liver disease (NAFLD). Oral Lacticaseibacillus paracasei has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in patients with NAFLD shows that taking 2 sachets daily for 3 months of a specific combination product (VSL#3) containing L. paracasei and other probiotics modestly decreases triglyceride levels and liver enzymes when compared with taking placebo. However, there was no change in body mass index or most glycemic or lipid parameters (111009). The effect of L. paracasei alone is unclear from this study.
• Osteoarthritis. It is unclear if oral Lacticaseibacillus paracasei is beneficial for osteoarthritis. Details: A large clinical trial in patients with mild to moderate symptoms of knee osteoarthritis shows that taking skim milk containing L. paracasei Shirota 6 billion colony-forming units twice daily for 6 months modestly improves stiffness, pain, and function when compared with taking skim milk placebo (111953). More research is needed to determine whether L. paracasei Shirota is as effective as standard medications.
• Pain (acute). It is unclear if oral Lacticaseibacillus paracasei is beneficial for acute pain. Details: Clinical research in patients with a single rib fracture shows that taking skim milk containing L. paracasei Shirota 6 billion colony-forming units daily for 1 month modestly reduces pain during deep breathing, coughing, and turning over when compared with taking skim milk placebo. Good pain relief during these situations, defined as a decline in maximal pain intensity of 3 points on a 10-point scale, occurred in 42.1% to 61.6% of patients, compared with 25.9% to 47.3% of patients taking placebo. However, there was no effect on sleep quality (111957).
• Parkinson disease. It is unclear if oral Lacticaseibacillus paracasei is beneficial for Parkinson disease. Details: Clinical research in patients with Parkinson disease shows that taking fermented milk providing L. paracasei Shirota 10 billion colony-forming units daily for 12 weeks reduces the use of laxatives by 0.37 or 15% per week and modestly improves stool consistency and symptoms of constipation when compared with taking an acidified milk placebo. There were also modest improvements in non-motor symptoms, anxiety, and depression, but not overall disease severity or dopaminergic therapy requirement (111956).
• Postoperative infection. Although there has been interest in using oral Lacticaseibacillus paracasei for preventing postoperative infections, there is insufficient reliable information about the clinical effects of L. paracasei for this purpose.
• Pouchitis. Oral Lacticaseibacillus paracasei has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research shows that continuous oral treatment for one year with a specific combination product (Visbiome, ExeGi Pharma) containing L. paracasei and other probiotics, 6 grams (300-500 billion live bacteria per gram) daily, for up to 12 months seems to maintain remission in 85% of patients with pouchitis (6087,12769).
• Pregnancy-induced nausea and vomiting. Oral Lacticaseibacillus paracasei has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small preliminary clinical trial shows that taking probiotics during pregnancy reduces the severity and duration of nausea and vomiting by 16% to 54%. There was also a small benefit on stool hardness. A specific probiotic (Probiotics 10, Nature's Bounty) was taken as 2 capsules daily for two back-to-back cycles of six days with probiotics and two days without. Each capsule contained a total of 10 billion colony-forming units (CFUs) of L. paracasei DSM 13434 and Lpc-37, Lactiplantibacillus plantarum 299v and DSM 15312, Lactobacillus delbrueckii subsp. bulgaricus Lb-87, Ligilactobacillus salivarius Ls-33, Levilactobacillus brevis Lbr-35, Lactobacillus acidophilus La-14, Lacticaseibacillus casei Lc-11, and Bifidobacterium animalis subsp. lactis Bl-04, along with inulin 200 mg (107199).
• Prostatitis. It is unclear if oral Lacticaseibacillus paracasei is beneficial for prostatitis. Details: Preliminary clinical research in adults with chronic bacterial prostatitis who are receiving antibiotic treatment shows that taking L. paracasei CNCM I-1572 (L. casei DG) one capsule twice daily for 6 months improves clinical symptoms over baseline in 73% of patients and also reduces symptomatic recurrence and antibiotic use (105133). The validity of these findings is limited by the lack of a comparator group.
• Proton pump inhibitor-induced gastrointestinal (GI) symptoms. It is unclear if oral Lacticaseibacillus paracasei is beneficial for preventing GI symptoms in patients using proton pump inhibitors. Details: Preliminary clinical research in patients with gastroesophageal reflux disease shows that taking L. paracasei F19 (Genefilus F19, Siffra Farmaceutici S.r.l., Italy) 24 billion colony-forming units 3 times a week for 3 or 6 months during treatment with pantoprazole 40 mg daily modestly reduces stool frequency and the severity and proportion of patients with flatulence and bloating when compared with taking placebo (111941).
• Radiation-induced diarrhea. Oral Lacticaseibacillus paracasei has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical trial in patients undergoing pelvic radiotherapy shows that taking 96 mL fermented milk (Danone) 3 times daily containing L. paracasei DN-114 001 100 million colony-forming units per gram starting one week before the initiation of radiation treatment does not delay the development of diarrhea when compared with taking a control sterilized milk product. The fermented milk was continued throughout treatment and made with the yogurt cultures Lactobacillus delbrueckii subsp. bulgaricus and Streptococcus thermophilus (112513).
• Rotaviral diarrhea. It is unclear if oral Lacticaseibacillus paracasei is beneficial for rotaviral diarrhea. Details: The current guidelines related to the treatment of viral diarrhea are conflicting. While the World Gastroenterology Organization has not made a recommendation (98471), the European Society for Pediatric Infectious Diseases recommends probiotics in hospitalized children with diarrhea (98469) and the Infectious Disease Society of America (IDSA) recommends probiotics for the outpatient treatment of acute diarrhea (95388). However, these guidelines note that most evidence is low quality and is not specific to rotavirus infection. Furthermore, these guidelines were released prior to the publication of the most recent, high-quality studies showing no benefit with the use of certain probiotics (98427,98428). Also, research on the use of L. paracasei, specifically, is lacking.
• Sarcopenia. Although there has been interest in using oral Lacticaseibacillus paracasei for sarcopenia prevention, there is insufficient reliable information about the clinical effects of L. paracasei for this purpose.
• Short bowel syndrome. Although there has been interest in using oral Lacticaseibacillus paracasei for short bowel syndrome, there is insufficient reliable information about the clinical effects of L. paracasei for this condition.
• Small intestinal bacterial overgrowth (SIBO). It is unclear if oral Lacticaseibacillus paracasei is beneficial for the treatment of SIBO. Details: One preliminary clinical study in adults with irritable bowel syndrome and a recent diagnosis of SIBO shows that consuming 65 mL of a specific product (Yakult, Yakult Ltd.) providing 6.5 billion colony-forming units (CFUs) of L. paracasei Shirota by mouth daily for 6 weeks modestly improves flatulence, but not other symptoms, when compared to baseline (91144).
• Ulcerative colitis. Oral Lacticaseibacillus paracasei has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: The best evidence of benefit is for a specific combination product (Visbiome, ExeGi Pharma). Doses of 3 grams (equivalent to 900 billion colony-forming units (CFUs)) once or twice daily have been used in combination with conventional treatment. In children aged 1-16 years, doses of 450-1800 billion CFUs for up to one year have been used (3261,14370,14371,16841,95337). A meta-analysis of clinical research shows that taking this product as an adjunct to standard ulcerative colitis treatment can increase remissions rates in adults and children by about 1.7-fold when compared with standard treatment alone (95337). There is also evidence that it is beneficial for improving remission rates in patients who do not adequately respond to conventional treatment (14371).
• Upper respiratory tract infection (URTI). Oral Lacticaseibacillus paracasei has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in children ages 3-6 years shows that taking taking fermented milk (DanActive, Dannon) containing L. paracasei DN-114 011 20 billion colony-forming units daily for 90 days reduces the incidence of URTIs by 18% when compared with taking a control non-fermented milk. The fermented milk was made with the yogurt cultures Lactobacillus delbrueckii subsp. bulgaricus and Streptococcus thermophilus (112515).
• Wound healing. It is unclear if oral Lacticaseibacillus paracasei is beneficial for the treatment of SIBO. Details: Clinical research in patients with a recent episiotomy shows that taking L. paracasei (L. casei 431) 1.5 billion colony-forming units daily for 14 days modestly improves wound severity, including redness, swelling, and discharge, 5 and 15 days after birth when compared with taking placebo. There was no effect on wound pain (112519). More evidence is needed to rate Lacticaseibacillus paracasei for these uses.

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LIKELY SAFE ...when live or heat-killed Lacticaseibacillus paracasei are used orally and appropriately. Live L. paracasei alone or in combination with other probiotics has been safely used in studies lasting up to 4 years (6087,14370,14371,35393,35407,103440,105133,107555,107557,110979)(111937,111938,111940,111943,111948,111950,111951,111953,111954,111955)(111958,111959,112512,112513,112518,112519). Non-viable, heat-killed L. paracasei has been safely used in studies lasting up to 3 months (111939,111940,111947). There is insufficient reliable information available about the safety of live or non-viable, heat-killed L. paracasei when used topically.

CHILDREN: LIKELY SAFE
when used orally and appropriately in children of most ages. Lacticaseibacillus paracasei alone or in combination with Limosilactobacillus fermentum has been used with apparent safety for up to 3 months in children 1-18 years old (98440). Also, live or heat-killed L. paracasei LP-33 has been used with apparent safety for 30 days in children aged 5 years and older (107532). In children ages 2-12 years, a specific combination product (Visbiome, ExeGi Pharma) containing L. paracasei and seven other probiotics has been used safely for 3 months (107497). Also, L. paracasei has been used with apparent safety in combination with Lactiplantibacillus plantarum for up to 12 weeks (107556). L. paracasei DN-114 011 has been taken safely for 90 days in children ages 3-6 years in fermented milk (DanActive, Dannon) (112515). There is insufficient reliable information available about the safety of L. paracasei in preterm infants with a birth weight under 1000 grams. Cases of bacteremia have occurred rarely in preterm infants given other probiotics (102416,111610,111612,111613,111850,111852,111853). The US Food and Drug Administration (FDA) has issued a warning about cases of serious infections caused by probiotics reported in very preterm or very low birth weight infants under 1000 grams (111610). Similarly, the American Academy of Pediatrics does not support the routine administration of probiotics to these infants due to conflicting data on safety and efficacy (111608).

PREGNANCY AND LACTATION: POSSIBLY SAFE
when used orally and appropriately. A combination of Lacticaseibacillus paracasei and Bifidobacterium longum from 2 months prior to delivery until 2 months after delivery has been used with apparent safety (90285).

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ANTIBIOTIC DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Mild •  Occurrence = Probable •  Level of Evidence = D Theoretically, taking Lacticaseibacillus paracasei with antibiotic drugs might decrease the effectiveness of L. paracasei.  Details L. paracasei preparations usually contain live and active organisms. Therefore, simultaneously taking antibiotics might kill a significant number of the organisms (1740). Tell patients to separate administration of antibiotics and L. paracasei preparations by at least two hours.

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General ...Orally, Lacticaseibacillus paracasei is generally well tolerated.
Most Common Adverse Effects:
Orally: Mild gastrointestinal adverse effects.
Serious Adverse Effects (Rare):
Orally: There is concern that Lacticaseibacillus paracasei may cause infections in some people.

Dermatologic ...Orally, in one clinical trial, a combination of Lacticaseibacillus paracasei subsp. paracasei F19, Lactobacillus acidophilus La-5, and Bifidobacterium animalis subsp. lactis BB-12 was associated with two cases of rash, one with itching. However, it is not clear if these adverse effects were due to L. paracasei, other ingredients, the combination, or if the events were idiosyncratic (90236).
Topically, a lotion containing the cell free supernatant of L. paracasei was rarely associated with erythema, itching, and scaling (111945).

Gastrointestinal ...Orally, taking Lacticaseibacillus paracasei alone or in combination with other probiotics may cause gastrointestinal side effects including dyspepsia (105133), flatulence (107497), nausea (111952), and bloating (107497,111952); however, these events are uncommon.
There are at least five case reports of acute cholecystitis for which a lactobacilli was thought to be the primary pathogen. In a 66-year-old female, vancomycin-resistant L. paracasei was the primary pathogen resulting in peritonitis secondary to a cholecystitis-induced gallbladder perforation. Although the patient reportedly ate 96-128 oz of yogurt each day, this yogurt was not believed to be associated with the cholecystitis (103443).

Immunologic ...Since Lacticaseibacillus paracasei preparations contain live and active microorganisms, there is some concern that they might cause pathogenic infection in some patients. Lactobacilli species, including L. paracasei, have been isolated in some cases of bacteremia, sepsis, splenic abscess, endocarditis, necrotizing fasciitis, pancreatic necrosis, meningoencephalitis, and prosthetic joint infections. Most cases of L. paracasei infection are thought to be due to the translocation of bacteria from other locations in the body in which it occurs naturally, such as the oral cavity and gastrointestinal tract (107543,111942,111944,111946,90282). However, there are case reports of L. paracasei infections thought to be at least partially related to dietary or supplemental intake (90254,107546,95393). In a 77-year-old male who consumed yogurt containing L. paracasei daily, L. paracasei bacteremia with endocarditis was thought to be related to bacterial translocation from the colon following a colonoscopy (90254). In a 78-year-old male, L. paracasei bacteremia and endocarditis was thought to be related to daily use of probiotics; however, the specific species included in the product were not mentioned. Also, the patient was diagnosed with an aortic valve stenosis and had undergone dental treatment approximately 6 months previously, possibly increasing the risk for development of bacteremia (95393). In an immunocompetent 45-year-old male with no history of heart disease, consumption of yogurt containing L. paracasei for about 2.5 years was thought to be associated with the development of endocarditis (107546).

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