An Early Phase 1 interventional study of Probiotic Strains in Healthy, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-19.
Sponsored by University of Florida · Early Phase 1, Interventional, and Basic science
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 the intervention, and the associations between detection and persistence with total gut transit time.
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 feces of healthy adults following the start and the end of IP intervention, respectively. This study will have an initial baseline period (4 weeks), a probiotic intervention (2 weeks) and a washout period (4 weeks). Participants will complete daily questionnaires regarding stool frequency, time of stool collections, and IP intake. A weekly Gastrointestinal Symptom Rating Scale (GSRS) questionnaire will be administered. Transit time will be assessed using radiopaque markers.
University of Florida is the lead sponsor of 1,285 studies on the registry; 199 are open to participants now.
Of its 177 completed or terminated interventional studies of FDA-regulated products, 141 (80%) have results posted.
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Exclusion Criteria:
Healthy adults will be given probiotic strains to evaluate the detection and persistence of the strains in the participant's feces.
Biological: Probiotic Strains
A commercial product containing L. helveticus R0052, L. casei HA-108, B. breve HA-129, and B. longum R0175 and S. thermophilus HA-110 be given to healthy adults across a 10-week open label pilot study.
Change in time to detection of probiotic strains
using strain-specific qPCR assays.
Time frame: Day 1; Day 2; Day 3, Day 4, Day 7, Day 10
Change in time to non-detection (persistence) of probiotic strains
using strain-specific qPCR assays.
Time frame: Day 14, Day 15, Day 16, Day 17, Day 18, Day 21, Day 24, Day 28, Day 35, Day 42
Whole gut transit time
Whole gut transit time measured by radiopaque marker recovery in intervention stools
Time frame: Day 1, Day 2, Day 3, Day 4
Plan to share: No
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This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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