| Ingredients | Amount Per Serving |
|---|---|
|
(DPP-IV)
(Dipeptidyl Peptidase IV (DPP IV) Blend)
|
200 mg |
|
(Protease I, Protease II, Protease III, Protease IV, Protease V)
|
|
|
Glucoamylase
|
|
|
Amylase
|
|
|
Cellulase
|
|
|
Beta-Glucanase
|
|
|
Alpha-Galactosidase
(AGS)
|
|
|
Xylanase
(Xylanase)
|
|
|
Herbal Blend
(Betaine HCl, Cranberry, Ginger, Golden Seal, Oregano, Rose Hips, Spearmint)
|
300 mg |
|
(Bacillus coagulans )
|
33 mg |
Cellulose, Stearic Acid (Alt. Name: C18:0)
Below is general information about the effectiveness of the known ingredients contained in the product ZGLUTn. 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
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
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.
Below is general information about the safety of the known ingredients contained in the product ZGLUTn. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
POSSIBLY SAFE ...when taken orally and appropriately. Bacillus coagulans spores in doses up to 6 billion colony-forming units (CFUs) daily have been used with apparent safety in clinical studies for up to 3 months (92726,92730,92734,92735,92736,92739,92740,104231,105169)(107611,107612,107614). Lower doses of B. coagulans up to 100 million CFUs daily have been used with apparent safety in clinical studies for up to one year (92738). There is insufficient reliable information available about the safety of non-viable, heat-killed B. coagulans formulations when used orally.
CHILDREN: POSSIBLY SAFE
when taken orally and appropriately.
Bacillus coagulans spores in doses up to 100 million colony-forming units (CFUs) daily have been used with apparent safety in clinical studies in infants of most ages for up to one year (92729,92733,92738) and in doses of one billion CFUs in children aged 6-8 years for 3 months (107615). There is insufficient reliable information available about the safety of Bacillus coagulans 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.
LIKELY SAFE ...when used orally and appropriately with lactose-containing foods. Lactase has Generally Recognized as Safe (GRAS) status in the US when prepared from Candida pseudotropicalis or Kluyveromyces lactis (104108,104109). Lactase has been used safely in doses up to 9900 international units (IU) and up to 13,500 food chemical codex (FCC) units (2371,2372,2373,106669).
CHILDREN: LIKELY SAFE
when used orally and appropriately with lactose-containing foods.
PREGNANCY AND LACTATION: LIKELY SAFE
when used orally and appropriately with lactose-containing foods.
There is insufficient reliable information available about the safety of lipase.
CHILDREN: POSSIBLY UNSAFE
when recombinant human bile salt-stimulated lipase (rhBSSL) is used orally by premature infants.
Adding rhBSSL to infant formula or pasteurized breast milk increases the risk for serious gastrointestinal adverse effects in premature infants (101940).
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
LIKELY SAFE ...when consumed in the amounts commonly found in foods. There is insufficient reliable information available about the safety of phytase when used orally as a supplement.
PREGNANCY AND LACTATION:
Insufficient reliable information is available; avoid using.
LIKELY SAFE ...when probiotic preparations containing Lactobacillus acidophilus, Lacticaseibacillus casei, Lacticaseibacillus paracasei, Lactiplantibacillus plantarum, Limosilactobacillus reuteri, Lacticaseibacillus rhamnosus, Bifidobacterium bifidum, Bifidobacterium breve, Bifidobacterium animalis subsp. lactis, and Bifidobacterium longum, Streptococcus thermophilus, and/or Saccharomyces boulardii are used orally and appropriately. These probiotics have been safely used in clinical trials. See individual topics for details. ...when probiotic preparations containing L. acidophilus, L. plantarum, or L. rhamnosus are used intravaginally and appropriately. These probiotics have been safely used in clinical trials. See individual topics for details.
POSSIBLY SAFE ...when Bacillus coagulans and Bacillus subtilis are used orally and appropriately. Bacillus coagulans and Bacillus subtilis spores have been used with apparent safety in clinical studies. ...when Lactiplantibacillus pentosus, Lactobacillus delbrueckii subsp. bulgaricus, Lactobacillus gasseri, Lactobacillus helveticus, Lactobacillus jensenii, Lactobacillus johnsonii, Latilactobacillus sakei, Levilactobacillus brevis, Ligilactobacillus salivarius, and/or Limosilactobacillus fermentum are used orally and appropriately. See individual topics for more specific information. ...when probiotic preparations containing Lactobacillus crispatus, L. brevis, L. fermentum, and/or L. gasseri are used intravaginally and appropriately. These probiotics have been safely used in clinical trials. See individual topics for details. There is insufficient reliable information available about the safety of other probiotics.
CHILDREN: LIKELY SAFE
when probiotic preparations containing Lactobacillus acidophilus, Lacticaseibacillus casei, Lacticaseibacillus paracasei, Lactiplantibacillus plantarum, Limosilactobacillus reuteri, Lacticaseibacillus rhamnosus, Bifidobacterium bifidum, Bifidobacterium breve, Bifidobacterium animalis subsp.
lactis, and Bifidobacterium longum are used orally and appropriately in children of most ages. These probiotics have been safely used in clinical trials. See individual topics for details.
CHILDREN: POSSIBLY SAFE
when probiotic preparations containing Bacillus coagulans, Lactobacillus gasseri, Lactobacillus helveticus, Lactobacillus johnsonii, Levilactobacillus brevis, Ligilactobacillus salivarius, Limosilactobacillus fermentum, Saccharomyces boulardii, and/or Streptococcus thermophilus are used orally and appropriately in children of most ages.
Cases of bacteremia have occurred rarely in preterm infants (102416,111610,111612,111613,111850,111852,111853). See individual topics for details. There is insufficient reliable information available about the safety of other probiotics in children or about the safety of probiotics in preterm infants with a birth weight under 1000 grams. 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 Lactobacillus acidophilus, Lacticaseibacillus casei, Lacticaseibacillus paracasei, Lactiplantibacillus plantarum, Ligilactobacillus salivarius, Limosilactobacillus reuteri, Lacticaseibacillus rhamnosus, Bifidobacterium bifidum, and Bifidobacterium longum are used orally and appropriately, short-term.
See individual topics for details.
There is insufficient reliable information available about the safety of other probiotics during pregnancy.
LACTATION: POSSIBLY SAFE
when Lacticaseibacillus paracasei, Limosilactobacillus fermentum, Limosilactobacillus reuteri, Lacticaseibacillus rhamnosus, and Bifidobacterium longum are used orally and appropriately, short-term.
See individual topics for details.
There is insufficient reliable information available about the safety of other probiotics during lactation.
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.
Below is general information about the interactions of the known ingredients contained in the product ZGLUTn. 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 antibiotics with Bacillus coagulans might decrease the effectiveness of B. coagulans.
 Details
B. coagulans preparations usually contain live and active organisms. Therefore, simultaneously taking antibiotics might kill a significant number of the organisms. Tell patients to separate administration of antibiotics and B. coagulans preparations by at least two hours.
|
Theoretically, taking antibiotic drugs with certain probiotics might decrease the effectiveness of probiotics.
Details
Many probiotics are bacteria. Since these preparations usually contain live and active organisms, simultaneously taking antibiotics might kill a significant number of sensitive organisms (1740,22802). Human research shows that taking probiotic concurrently with antibiotic treatment does not affect the diversity of the gut microbiome compared with antibiotic treatment in the absence of probiotics (112662). Tell patients to separate administration of antibiotics and these preparations by at least two hours.
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Theoretically, taking antifungals with certain probiotics might decrease the effectiveness of probiotics.
Details
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Below is general information about the adverse effects of the known ingredients contained in the product ZGLUTn. 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, Bacillus coagulans is well tolerated.
Serious Adverse Effects (Rare):
Orally: There is concern that probiotics may cause infections in some people.
Immunologic ...Since many probiotic preparations contain live and active microorganisms, there is some concern that they might cause pathogenic infection in some patients. Bacteremia and sepsis have been reported in patients with indwelling or central venous catheters or patients who are severely ill and/or immunocompromised, including preterm infants, that were using probiotic products (4380,8561,13008,13070,90298,102416,103444,105138,105140,105141)(107543,107597,107599,111610,111612,111613,111850,111852,111853). However, reports of pathogenic colonization in relatively healthy patients with intact immune systems who do not have indwelling or central venous catheters are extremely rare (4380,4389,4390,4391,4393,4398,105139,107543,107545,107546,107547).
General ...Orally, lactase is generally well tolerated.
Immunologic ...A case of lactase-induced contact dermatitis and immunoglobulin E (IgE)-mediated allergic rhinoconjunctivitis has been reported in a worker exposed to powdered lactase. Allergy to lactase was confirmed by prick test, open application test, and chamber challenge test (96348).
General
...No adverse effects have been reported in adults.
However, a thorough evaluation of safety outcomes has not been conducted.
Serious Adverse Effects (Rare):
Orally: Gastrointestinal adverse effects, such as necrotizing enterocolitis, when recombinant human bile salt-stimulated lipase is used in premature infants.
Gastrointestinal ...Orally, when added to the formula or pasteurized breast milk consumed by premature infants, recombinant human bile salt-stimulated lipase (rhBSSL) can cause gastrointestinal adverse effects, including abdominal distension, flatulence, constipation, colic, abdominal pain, gastroenteritis, vomiting, regurgitation, and rectal bleeding (101940). Premature infants receiving rhBSSL also had a slightly higher rate of necrotizing enterocolitis (NEC) when compared with those receiving placebo. After review by a panel of experts, it was determined that the rate of confirmed or suspected NEC in infants consuming rhBSSL was 3.3%, compared with 0.5% in those receiving placebo. Although this rate of NEC is lower than the historical rate of occurrence in premature infants (11%), a possible increased risk for NEC cannot be ruled out (101940).
General ...Orally, no adverse effects have been reported. However, a thorough evaluation of safety outcomes has not been conducted. Workplace immunological responses to airborne powdered phytase have been reported (101901,101908,101909,101910).
Immunologic ...There are numerous reports of immunologic responses to airborne powdered phytase in the animal-feed industry (101901,101908,101909,101910). Examples of reactions include allergic occupational asthma and hypersensitivity pneumonitis (101901,101908). In one case report of a 43-year-old male, hypersensitivity pneumonitis related to phytase was diagnosed following a 6-month history of coughing, shortness of breath, fever, and dyspnea (101908). In an analysis of 53 people occupationally exposed to phytase, 28% had IgE antibodies and 45% had IgG antibodies specific to phytase. Symptoms included dyspnea, rhinitis, and eye and skin reactions (101909). In another analysis of patients with IgE-mediated occupational respiratory allergy, wheezing, chest tightness, shortness of breath, cough, and asthmatic symptoms were reported (101910).
General
...Orally and intravaginally, probiotics are generally well tolerated.
Most Common Adverse Effects:
Orally: Mild gastrointestinal adverse effects.
Serious Adverse Effects (Rare):
Orally: There is concern that probiotics may cause infections in some people.
Dermatologic ...Orally, probiotics have been reported to cause rare cases of rash (90236), itching and redness (110848), and dermatitis (93707). See individual topics for details.
Gastrointestinal ...Orally, gastrointestinal adverse effects such as diarrhea, dyspepsia, abdominal pain, nausea, vomiting, bloating, belching, and flatulence have been reported rarely with probiotics (2,3169,16841,90235,90239,90271,90291,95381,107520,110846)(110867,110942,110946,110959,110962,110986,110999,111785,112674). See individual topics for details.
Immunologic
...Since many probiotic preparations contain live and active microorganisms, there is some concern that they might cause pathogenic infection in some patients.
Bacteremia and sepsis have been reported in patients with indwelling or central venous catheters or patients who are severely ill and/or immunocompromised, including preterm infants, that were using probiotic products (4380,8561,13008,13070,90298,102416,103444,105138,105140,105141)(107543,107597,107599,111610,111612,111613,111850,111852,111853,112499)(112505,112509,112520,112668). However, reports of pathogenic colonization in relatively healthy patients with intact immune systems who do not have indwelling or central venous catheters are extremely rare (4380,4389,4390,4391,4393,4398,105139,107543,107545,107546,107547). See individual topics for details.
Rarely, oral use of Saccharomyces boulardii has been associated with fungemia in both immunocompromised and immunocompetent patients, including preterm infants (1247,4357,4358,4360,7329,14459,72121,72126,72142,92809,95357,95363,105171). 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 powder were used or when Saccharomyces capsules were opened at the bedside (12776,12777,14459,95358,95360,95362,95363,105171).
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).
