Acidophilus Pearls Fecal Recovery Study

NCT ID: NCT02001610

Last Updated: 2017-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-05-31

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 (Unpublished studies conducted at SNA research facility, February, 2010.)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

Conditions

Survival of Probiotics During GI Transit; GI Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Hard shell gelatin capsules

Intervention Type: DIETARY_SUPPLEMENT

• 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

Acidophilus pearls

• Encapsulated using patented process
• One capsule (containing at least 1 x 10^9 colony forming units) every morning for 12 days

Group Type: EXPERIMENTAL

Acidophilus pearls

Intervention Type: DIETARY_SUPPLEMENT

• 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

Interventions

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

Intervention Type: 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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Schwabe North America

INDUSTRY

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Volker Mai, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

Emerging Pathogens Institute

Gainesville, Florida, United States

Countries

United States

Other Identifiers

PS Project 00090915

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201300549

Identifier Type: -

Identifier Source: org_study_id