NCT06686420

Investigation of the Effects of a Bifidobacterial Strain on Bowel Movement in Healthy Adults

A Randomized, Double-blind, Placebo-controlled, Parallel Study, to Assess the Effect of Bifidobacterial Supplementation on Bowel Movements.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Morinaga Milk Industry Co., LTD · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Infrequent Bowel Movements

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	B. longum	On the first day of the intervention period, participants will be instructed to consume two capsules of the live B. longum strain daily with a glass of water before breakfast for the next eight weeks.
DIETARY_SUPPLEMENT	Placebo	On the first day of the intervention period, participants will be instructed to consume two capsules, which are without any live bacteria, daily. They should take these before breakfast with a glass of water, for the following eight weeks.

Timeline

• Start date: 2024-05-01
• Primary completion: 2025-08-31
• Completion: 2026-12-31
• First posted: 2024-11-13
• Last updated: 2025-09-11

Locations

1 site across 1 country: United States