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

NCT06686420 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-09-11

No results posted yet for this study

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.

Conditions

  • Infrequent Bowel Movements

Interventions

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.

Sponsors & Collaborators

  • Morinaga Milk Industry Co., LTD

    lead INDUSTRY

Principal Investigators

  • Stacey Boetto · STTI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2025-08-31
Completion
2026-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06686420 on ClinicalTrials.gov