Acidophilus Pearls Fecal Recovery Study

Not Applicable

Completed

• Conditions: Survival of Probiotics During GI Transit; GI Symptoms
• Interventions: Dietary Supplement: Hard shell gelatin capsules; Dietary Supplement: Acidophilus pearls

• Registration Number: NCT02001610
• Lead Sponsor: University of Florida

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 (Unpublished studies conducted at SNA research facility, February, 2010.)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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-11-22
• Study First Submitted QC: 2013-11-27
• Study First Posted: 2013-12-05
• Study Start: 2014-03
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-06
• Last Update Posted: 2017-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hard shell gelatin capsules	Hard shell gelatin capsules	* 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
Acidophilus pearls	Acidophilus pearls	* Encapsulated using patented process * One capsule (containing at least 1 x 10\^9 colony forming units) every morning for 12 days

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
GI symptoms	Day 7-9 and day 10-12	Change in GI symptoms using a weekly questionnaire.

Trial Locations

Locations (1)

Emerging Pathogens Institute; 🇺🇸 Gainesville, Florida, United States