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Completed

NCT Number: NCT02001610

Acidophilus Pearls Fecal Recovery Study

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 (Unpublished studies conducted at SNA research facility, February, 2010.)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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emerging Pathogens Institute

Gainesville, Florida, 32610, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acidophilus pearls

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

Hard shell gelatin capsules

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

Primary outcomes

  1. Change in fecal survival of probiotics

    Time frame: 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 outcomes

  1. GI symptoms

    Time frame: Day 7-9 and day 10-12

    Change in GI symptoms using a weekly questionnaire.

Other outcomes

  1. Fecal markers

    Time frame: Day 0 (before start of intervention), Day5-7 , Day 10-12 (end of intervention) and Day 17-19

    The investigators will measure fecal markers. This includes stool consistency on Bristol scale and pH.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Schwabe North America

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Dec 5, 2013
Registry last updated
Feb 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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