NCT04065503

Probiotic Detection and Persistence Study

Detection and Persistence of a Product Containing L. Helveticus R-0052, L. Casei HA-108, B. Breve HA-129, B. Longum R-0175 and S. Thermophilus HA-110 in Healthy Adults: an Open-label Pilot Study.

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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 the intervention, and the associations between detection and persistence with total gut transit time.

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 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.

Conditions

• Healthy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-12-06
• Primary completion: 2020-02-26
• Completion: 2020-12-31
• First posted: 2019-08-22
• Last updated: 2021-01-19

Locations

1 site across 1 country: United States