Status:
COMPLETED
Probiotic Detection and Persistence Study
Lead Sponsor:
University of Florida
Collaborating Sponsors:
Lallemand Health Solutions, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
EARLY_PHASE1
Brief Summary
The aims of this study are to determine how long it takes for the strains of a probiotic formulation to be detected in feces after the start of an intervention, how long they persist after the end of ...
Detailed Description
This is a 10-week interventional, open-label pilot study designed to evaluate the detection and persistence of L. helveticus R-0052, L. casei NI319, B. breve NI337, and B. longum R-0175 strains in fec...
Eligibility Criteria
Inclusion
- Healthy adults ≥ 18 to \< 55 years of age.
- Habitually produces at least one bowel movement per day.
- Willingness to maintain their usual diet and exercise patterns throughout the study.
- Able to provide written informed consent in English.
- Willing to provide stools and complete questionnaires, records, and diaries associated with the study and to complete all study visits.
- Willingness to discontinue consumption of probiotics and fermented products (e.g. yogurts, kombucha, fermented pickles and other fermented foods with live, active cultures) and probiotic supplements.
Exclusion
- Elite athletes or long-distance runners.
- Concurrent consumption of fermented foods or probiotics. However, individuals will be eligible for participation after a four (4) week wash-out period.
- Known to be pregnant (self-disclosure) or breastfeeding or planning on becoming pregnant in the next 2 months.
- Use of antibiotic drugs (e.g., neomycin, rifaximin) within 1 month of the screening visit. The screened participant would be eligible to participate four (4) weeks after completing their course of antibiotics (washout period).
- Use of other investigational products within 3 months of the screening visit.
- Previously or are currently being treated for any previously or currently being treated for any intestinal disease or condition such as IBS, Crohn's disease, ulcerative colitis, celiac disease, or gastrointestinal cancer.
- Immune disorders or with possible immune deficient status (e.g. due to surgery).
- Milk or soy allergy.
Key Trial Info
Start Date :
December 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04065503
Start Date
December 6 2019
End Date
December 31 2020
Last Update
January 19 2021
Active Locations (1)
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1
Food Science and Human Nutrition Department
Gainesville, Florida, United States, 32611