Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-30 @ 1:40 AM
Study NCT ID:
NCT04065503
Status:
COMPLETED
Last Update Posted:
2021-01-19
First Post:
2019-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Probiotic Detection and Persistence Study
Sponsor:
University of Florida
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: