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Acidophilus Pearls Fecal Recovery Study

NCT02001610 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2017-02-08

No results posted yet for this study

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 (Unpublished studies conducted at SNA research facility, February, 2010.)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

Interventions

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

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

Sponsors & Collaborators

  • Schwabe North America

    collaborator INDUSTRY

  • University of Florida

    lead OTHER

Principal Investigators

  • Volker Mai, PhD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02001610 on ClinicalTrials.gov