Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-29 @ 9:32 PM
Study NCT ID:
NCT01802151
Status:
COMPLETED
Last Update Posted:
2015-12-17
First Post:
2013-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Bacillus Subtilis R0179 in Healthy Young Adults
Sponsor:
University of Florida
Organization:
Study Overview
Official Title:
Evaluation of Bacillus Subtilis R0179 in Capsules on Gastrointestinal Survival, Transit Time, Gastrointestinal Symptoms, and General Wellness in Healthy Young Adults
Status:
COMPLETED
Status Verified Date:
2015-11
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 purpose of this study is to evaluate the effect of three doses of the probiotic B. subtilis (Bacillus subtilis R0179) delivered in capsules on gastrointestinal and general wellness in healthy young adults, survival through the gastrointestinal tract and impact on intestinal microbes.
Detailed Description:
A 6 week randomized, double blind placebo controlled trial in healthy young adults aged 18 to 50. Participants will be administered an oral dose of B. subtilis or placebo (1 capsule/day) for a period of 4 weeks. Viable counts will be measured from stool samples to assess transit survival, daily questionnaires (DQ) will be administered to assess general wellness, and gastrointestinal (GI) symptoms will be evaluated three times with the Gastrointestinal Symptom Response Scale (GSRS) questionnaire.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: