Acidophilus Pearls Fecal Recovery Study

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

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 (Unpublished studies conducted at SNA research facility, February, 2010.)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

Study Overview

• Status: Completed
• Conditions: Survival of Probiotics During GI Transit; GI Symptoms
• Intervention / Treatment: Dietary supplement: Hard shell gelatin capsules; Dietary supplement: Acidophilus pearls

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • Emerging Pathogens Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Dietary supplement: Hard 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
Experimental: Acidophilus pearls; 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; 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fecal markers	The investigators will measure fecal markers. This includes stool consistency on Bristol scale and pH.	Day 0 (before start of intervention), Day5-7 , Day 10-12 (end of intervention) and Day 17-19

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Schwabe North America

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: November 22, 2013
• First Submitted That Met QC Criteria: November 27, 2013
• First Posted (Estimate): December 5, 2013

Study Record Updates

• Last Update Posted (Estimate): February 8, 2017
• Last Update Submitted That Met QC Criteria: February 6, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: probiotics; microbiota; fecal markers
• Other Study ID Numbers: IRB201300549; PS Project 00090915 (Other Identifier: University of Florida)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No