Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-01-17 @ 11:21 AM
Study NCT ID:
NCT06686420
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-11
First Post:
2024-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Effects of a Bifidobacterial Strain on Bowel Movement in Healthy Adults
Sponsor:
Morinaga Milk Industry Co., LTD
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Placebo-controlled, Parallel Study, to Assess the Effect of Bifidobacterial Supplementation on Bowel Movements.
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
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 goal of this clinical trial is to investigate whether a supplement containing the B. longum strain works to alleviate constipation in adults.
The main questions it aims to answer are:
Does a supplement containing the B. longum strain increase the number of spontaneous bowel movements per week, improve stool consistency, and enhance the quality of life?
Participants will:
Take a supplement containing the B. longum strain or a placebo every day for 8 weeks.
Maintain an e-diary as per the instructions. Visit the clinic for screening assessments, baseline, and end of the intervention for stool sample submission.
The main questions it aims to answer are:
Does a supplement containing the B. longum strain increase the number of spontaneous bowel movements per week, improve stool consistency, and enhance the quality of life?
Participants will:
Take a supplement containing the B. longum strain or a placebo every day for 8 weeks.
Maintain an e-diary as per the instructions. Visit the clinic for screening assessments, baseline, and end of the intervention for stool sample submission.
Detailed Description:
Constipation significantly impacts the quality of life, and one of the main causes is the disruption of the gut microbiota. Probiotics have been reported to have a beneficial effect on the intestines, and Bifidobacteria, in particular, have shown functionality in relieving constipation.This randomized, placebo-controlled, clinical trial investigates the effect of Bifidobacterial supplementation intervention on bowel movement in healthy adults.
Study Oversight
Has Oversight DMC:
False
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?: