GI Symptoms, Survival of Probiotics During GI Transit
Conditions
Keywords
microbiota, probiotics, fecal markers
Brief summary
Commercial probiotics can be delivered in numerous forms. The two most common delivery forms are similar to the two product formats to be tested. It has been demonstrated using in vitro testing that probiotic organisms that are unprotected from gastric exposure may not survive that exposure and therefore may not remain viable throughout the rest of the GIT. (Unpublished studies conducted at SNA research facility, February, 2010.) Similar in vitro testing of Acidophilus Pearls has demonstrated the probiotic organisms in an enteric capsule will survive gastric exposure. It is anticipated that this difference in in vitro gastric survivability will translate to improved digestive tract survivability that can be demonstrated using fecal recovery techniques. The commercial product to be tested in this clinical trial has been in the market for over 17 years. However, it is not known what effect this commercial product has on the commensal probiotic population in the gut and particularly in the lower bowel where much of probiotic benefits are believed to be largely realized. Also, it is not known what effect the commercial product has on the total commensal microbiota or fecal pH. While commercial probiotic products have been largely aimed at benefits related to improved health, they also have the potential to change overall gut microbiota (probiotics as well as all others) composition and activities. Learning what happens to the overall gut microbiota can be a helpful step in establishing the potential health benefits of the probiotic class of organisms in the test products.
Interventions
DIETARY_SUPPLEMENTAcidophilus pearls
* Acidophilus pearls are encapsulated using patented process * Subjects take one capsule (containing at least 1 x 10\^9 colony forming units) every morning for 12 days
DIETARY_SUPPLEMENTHard shell gelatin capsules
* Hard-shelled gelatin capsule with same microbial formulation as pearl supplement * Subjects consume one capsule (containing at least 1 x 10\^9 colony forming units) every morning for 12 days
Sponsors
Schwabe North America
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult * Regular and predictable bowel movement pattern * Willing to disclose OTC/prescription medications and dietary supplements taken during the study * Willing to sign comprehensive informed consent form
Exclusion criteria
* Digestive disorders * Use of prescribed medications that affect bowel function or microbiota (antibiotics, pain medications, laxatives) * Use of dietary supplements/foods that can affect bowel function or microbiota * Excessive alcohol use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in fecal survival of probiotics | Day 0 (before start of intervention), Day5-7 , Day 10-12 (end of intervention) and Day 17-19 | The investigators will measure survival of the probiotics in fecal samples. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GI symptoms | Day 7-9 and day 10-12 | Change in GI symptoms using a weekly questionnaire. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Fecal markers | Day 0 (before start of intervention), Day5-7 , Day 10-12 (end of intervention) and Day 17-19 | The investigators will measure fecal markers. This includes stool consistency on Bristol scale and pH. |
Countries
United States
Outcome results
None listed