Ingredients | Amount Per Serving |
---|---|
Protease Blend
(200,000 HUT)
|
|
Bacterial Protease
|
|
Protease S, Serrapeptase
|
|
Glucoamylase
(100 AGU)
|
|
Amylase
(5000 DU)
|
|
Probiotic Blend
(2 Billion CFU)
|
|
(Bacillus coagulans )
|
|
Bacillus subtilis
(Bacillus subtilis )
|
|
Cellulase
(1600 CU)
|
|
Hemicellulase
(2000 HCU)
|
|
(200 FIP)
|
Hydroxypropyl Methylcellulose (Alt. Name: HPMC), Water, low moisture Rice Dextrin, EDTA, Medium Chain Triglycerides (Alt. Name: MCTs)
Below is general information about the effectiveness of the known ingredients contained in the product Restore 3. 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
Below is general information about the safety of the known ingredients contained in the product Restore 3. 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.
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.
Below is general information about the interactions of the known ingredients contained in the product Restore 3. 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.
|
Below is general information about the adverse effects of the known ingredients contained in the product Restore 3. 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
...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).