| Ingredients | Amount Per Serving |
|---|---|
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Proprietary Multi-Enzyme Blend
|
189 mg |
|
(EndoPeptidase Note: 75,000 HUT )
|
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(Protease Note: 500 SAPU )
|
|
|
Exopeptidase
(Exopeptidase Note: 125 DPPIV )
|
|
|
Probiotic Blend
(5 billion live organisms)
(Probiotic Blend Note: 5 billion live organisms )
|
|
|
(Saccharomyces boulardii )
|
|
|
Bacillus subtilis strain DE111
(Bacillus subtilis )
|
|
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(Lactobacillus acidophilus )
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|
|
Prebiotic
(PreForPro)
|
7.5 mg |
|
LH01 - Myoviridae
|
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LL5 - Siphoviridae
|
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T4D - Myoviridae
|
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LL12 - Myoviridae
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Rice Bran PlantPart: bran, HPMC Note: vegetable capsule, Water Note: vegetable capsule, Medium Chain Triglycerides
Below is general information about the effectiveness of the known ingredients contained in the product Glutenza. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
INSUFFICIENT RELIABLE EVIDENCE to RATE
Proteolytic enzymes represent a wide group of enzymes that are used alone or in combination. See specific monographs for effectiveness information.
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product Glutenza. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
LIKELY SAFE ...when used orally and appropriately. Lactobacillus acidophilus has been safely used as part of multi-ingredient probiotic products in studies lasting up to nine months (1731,6087,14370,14371,90231,90296,92255,103438,12775,107581)(110950,110970,110979,110998,111785,111793). ...when used intravaginally and appropriately. L. acidophilus has been used safely in studies lasting up to 12 weeks (12108,13176,13177,90265). There is insufficient reliable information available about the safety of non-viable, heat-killed L. acidophilus formulations when used orally.
CHILDREN: LIKELY SAFE
when used orally and appropriately in children of most ages.
Lactobacillus acidophilus has been safely used for up to 5 days (96887). Also, combination probiotics containing L. acidophilus have been used with apparent safety in various doses and durations. L. acidophilus has been combined with Bifidobacterium animalis (HOWARU Protect, Danisco) for up to 6 months in children 3-5 years old (16847), with Bifidobacterium bifidum for 6 weeks (90602,96890), with Bifidobacterium bifidum and Bifidobacterium animalis subsp. lactis (Complete Probiotic Platinum) for 18 months in children 4 months to 5 years of age (103436), and in a specific product (Visbiome, ExeGi Pharma) containing a total of 8 species for 3 months in children 2-12 years old (107497). There is insufficient reliable information available about the safety of L. acidophilus 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: POSSIBLY SAFE
when used orally and appropriately.
A combination of Lactobacillus acidophilus, Lacticaseibacillus casei, and Bifidobacterium bifidum has been used with apparent safety for 6 weeks, starting at 24-28 weeks' gestation (95416,98430).
LACTATION:
There is insufficient reliable information available about the safety of Lactobacillus acidophilus during lactation.
However, there are currently no reasons to expect safety concerns when used appropriately.
POSSIBLY SAFE ...when used orally and appropriately. Various proteolytic enzymes have been safely used orally in clinical research (716,964,965,968,969,6252,6253,10622,11457,18281,18284) (91104,91105,91106,91111,96449). Side effects are typically mild to moderate and most often include gastrointestinal effects. See specific monographs for more detailed information related to the safety of individual proteolytic enzymes. ...when used topically and appropriately. Various proteolytic enzymes have been safely used topically in clinical research (67835,67843,67845,91113). Some proteolytic enzymes might cause allergic reactions when used topically. See specific monographs for more detailed information related to the safety of individual proteolytic enzymes.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when used orally and appropriately for up to 15 months (155,4347,4350,4351,4352,4353,4354,7140,7646,7652),(12763,14334,14379,14380,14381,72194,72198).
CHILDREN: POSSIBLY SAFE
when used orally and appropriately in children of most ages (4347,4356,14334,72145,92806,98734,103451,107603,107605,111102)(111103).
There is insufficient reliable information available about the safety of Saccharomyces boulardii 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:
Insufficient reliable information available; avoid using.
Below is general information about the interactions of the known ingredients contained in the product Glutenza. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Theoretically, taking Lactobacillus acidophilus with antibiotic drugs might decrease the effectiveness of L. acidophilus.
 Details
L. acidophilus 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. acidophilus preparations by at least two hours.
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Theoretically, taking antifungals with Saccharomyces boulardii might decrease the effectiveness of Saccharomyces boulardii.
Details
S. boulardii is a live yeast. Therefore, simultaneously taking antifungals might kill a significant number of the organisms (4363).
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Below is general information about the adverse effects of the known ingredients contained in the product Glutenza. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
General
...Orally and intravaginally, Lactobacillus acidophilus is generally well tolerated.
Most Common Adverse Effects:
Orally: Mild gastrointestinal adverse effects.
Intravaginally: Vaginal discharge.
Serious Adverse Effects (Rare):
Orally: There is concern that L. acidophilus may cause infections in some people.
Dermatologic ...Orally, in one clinical trial, a combination of Lactobacillus acidophilus La-5, Lacticaseibacillus paracasei subsp. paracasei F19, and Bifidobacterium animalis subsp. lacltis 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. acidophilus, other ingredients, the combination, or if the events were idiosyncratic (90236).
Gastrointestinal ...Orally, taking Lactobacillus acidophilus in combination with other probiotics may cause gastrointestinal side effects including epigastric discomfort (90239), abdominal pain (90239,90291,111785), dyspepsia (90239), flatulence (107497,107520), bloating (107497,111785), diarrhea (111785), vomiting (107537), and burping (90239); however, these events are uncommon.
Genitourinary ...Intravaginally, cream containing Lactobacillus acidophilus has been shown to cause increased vaginal discharge in about 5% of patients, compared to about 1% of patients receiving placebo cream (90237). Vaginal burning was reported by one person using intravaginal L. acidophilus and Limosilactobacillus fermentum in a clinical trial (111781).
Immunologic ...Since Lactobacillus acidophilus preparations contain live and active microorganisms, there is some concern that they might cause pathogenic infection in some patients. L. acidophilus has been isolated in some cases of bacteremia, sepsis, splenic abscess, liver abscess, endocarditis, necrotizing fasciitis, pancreatic necrosis, and meningoencephalitis. Most of these cases are thought to be due to the translocation of bacteria from other locations in the body in which they occur naturally, such as the oral cavity and gastrointestinal tract (107543,111782,111792). L. acidophilus endophthalmitis has been reported rarely (111787,111795). In one case, it was related to intravitreal injections for age-related macular degeneration in a 90-year-old female with an intraocular lens (111787). In another, it occurred following cataract surgery (111795).
General
...Orally, proteolytic enzymes are generally well tolerated.
See specific monographs for detailed safety information related to individual proteolytic enzymes.
Most Common Adverse Effects:
Orally: Gastrointestinal upset.
Serious Adverse Effects (Rare):
Topically: Allergic reactions.
Gastrointestinal ...Orally, some patients taking proteolytic enzymes may have gastrointestinal complaints (101517).
Immunologic ...Proteolytic enzymes are commonly found in laundry detergents and pre-spotter products. Rarely, protease specific IgE positive tests possibly related to these products have occurred. Exposure may be airborne or topical (102705). In addition, in case reports, occupational exposure to the airborne proteolytic enzyme pepsin has resulted in allergic rhinoconjunctivitis or asthma (102706,102707).
General
...Orally, Saccharomyces boulardii is generally well tolerated.
Serious Adverse Effects (Rare):
Orally: There is concern that Saccharomyces boulardii may cause fungemia in certain patients.
Gastrointestinal ...Rarely, oral use of Saccharomyces boulardii has caused gastrointestinal complaints, such as abdominal cramps, flatulence, nausea, vomiting, and decreased appetite (98731,107608).
Immunologic
...Rarely, oral use of Saccharomyces boulardii has been associated with fungemia in both immunocompromised and immunocompetent patients (1247,4357,4358,4360,7329,14459,72121,72126,72142,92809,95357,95363)(96277,105171,107604,107607).
Numerous cases of Saccharomyces fungemia have been reported in critically ill intensive care unit (ICU) patients, particularly those with indwelling or central venous catheters, those receiving enteral feeding, or those receiving broad-spectrum antibiotics. Most infections occurred when packets of Saccharomyces were used or when Saccharomyces capsules were opened at the bedside (12776,12777,14459,95358,95360,95362,95363,105171). Admission to the ICU and extended length of stay increase the risk of developing Saccharomyces fungemia (107604). In a hospitalized 1-year-old patient with severe malnutrition and multiple invasive devices, Saccharomyces cerevisiae fungemia developed 2 days after receiving a probiotic containing S. boulardii 200 mg twice daily for 4 days (96277). In addition, there are two case reports of S. cerevisiae fungemia in hospitalized and intubated older patients with COVID-19 who had been given S. boulardii for diarrhea (105171).
The true incidence of fungemia is difficult to determine with S. boulardii. Most clinical laboratories are unable to differentiate between S. boulardii and S. cerevisiae, which might come from other sources (7353). In two case reports of patients in the ICU, there was a 100% alignment of fungal ribosomal DNA ITS sequences between the strains found in the blood of the infected patients and the strains of S. boulardii that had been administered (105171). In a large analysis of hospitalized patients, the incidence rate of Saccharomyces fungemia was 0.11% of those given S. boulardii and did not occur in patients not given this probiotic. Packets or capsules opened at a distance from the patient in the hospital were included in this analysis (107604).
Positive Saccharomyces cultures have also been obtained rarely from other sites, such as the abdominal region and the oral or respiratory tract (107607).
An elevated erythrocyte sedimentation rate may occur when S. boulardii is used to treat Crohn disease (7646), but this effect may be a natural part of the disease process.
