Clinical trial NCT02001610: Acidophilus Pearls Fecal Recovery Study
Official title: Clinical Trial of the Viability of LAB and Bifidobacteria From Acidophilus Pearls in Human Stool Samples
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Survival of Probiotics During GI Transit
GI Symptoms
Keywords: microbiota
probiotics
fecal markers
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Schwabe North America
First posted: 2013-12-05
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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 (Unpublished studies conducted at SNA research facility, February, 2010.)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


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

Primary outcomes:
measure: Change in fecal survival of probiotics
timeFrame: Day 0 (before start of intervention), Day5-7 , Day 10-12 (end of intervention) and Day 17-19
Secondary outcomes:
measure: GI symptoms
timeFrame: Day 7-9 and day 10-12
Other outcomes:
measure: Fecal markers
timeFrame: Day 0 (before start of intervention), Day5-7 , Day 10-12 (end of intervention) and Day 17-19
Locations:
city: Gainesville
country: United States
facility: Emerging Pathogens Institute
state: Florida
Study officials:
affiliation: University of Florida
name: Volker Mai, PhD
role: PRINCIPAL_INVESTIGATOR
References: