Acidophilus Pearls Fecal Recovery Study

Study Overview
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Brief Summary
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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 (Unpublished studies conducted at SNA research facility, February, 2010.)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.

Official Title
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Clinical Trial of the Viability of LAB and Bifidobacteria From Acidophilus Pearls in Human Stool Samples

Conditions
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Survival of Probiotics During GI Transit, GI Symptoms

Intervention / Treatment
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* Dietary Supplement: Acidophilus pearls
* Dietary Supplement: Hard shell gelatin capsules


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hard shell gelatin capsules<br>Comparison delivery vehicle in the form of gelatin capsule One capsule (containing at least 1 x 10^9 colony forming units) every morning for 12 days | Dietary Supplement: Hard shell gelatin capsules<br>* 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<br>|
| Experimental: Acidophilus pearls<br>Encapsulated using patented process One capsule (containing at least 1 x 10^9 colony forming units) every morning for 12 days | Dietary Supplement: Acidophilus pearls<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fecal survival of probiotics | The investigators will measure survival of the probiotics in fecal samples. | Day 0 (before start of intervention), Day5-7 , Day 10-12 (end of intervention) and Day 17-19 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GI symptoms | Change in GI symptoms using a weekly questionnaire. | Day 7-9 and day 10-12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microbiota, probiotics, fecal markers