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Probiotic

Bifidobacterial Supplement for Constipation

N/A
Recruiting
Led By Stacey Boetto
Research Sponsored by Morinaga Milk Industry Co., LTD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults aged ≥18 years and ≤65 years
Experience less than 3 bowel movements per week within the past three months
Must not have
Participants currently of biological childbearing potential, but not using continuous effective method of contraception
Individuals who are cognitively impaired and/or who are unable to give informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to week 2, week 4 and week 6

Summary

This trial aims to see if a supplement with a specific strain of bacteria can help with constipation in adults. Participants will take the supplement or a placebo for 8 weeks, keep a daily diary,

Who is the study for?
This trial is for healthy adults who are experiencing constipation. Participants will take a daily supplement containing the B. longum strain or a placebo for 8 weeks and keep an e-diary of their bowel movements. They must visit the clinic at the start and end of the study to submit stool samples.
What is being tested?
The trial is testing if taking a supplement with B. longum can increase spontaneous bowel movements, improve stool consistency, and enhance quality of life compared to a placebo in adults with constipation over an 8-week period.
What are the potential side effects?
Potential side effects from taking B. longum may include digestive discomfort such as gas, bloating, or an upset stomach; however, since it's generally considered safe for consumption, severe side effects are unlikely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I have had fewer than 3 bowel movements weekly for the last 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I can have children but am not using any form of birth control.
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I am unable to understand or sign a consent form due to cognitive issues.
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I am allergic to ingredients in the study medication.
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I am taking oral antibiotics and will continue to do so throughout the study.
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I have a diagnosed gastrointestinal condition or have had major GI surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to week 2, week 4 and week 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 2, week 4 and week 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change in SBM frequency
Change in stool consistency
Patient Assessment of Constipation Quality of Life (PAC-QoL) Questionnaire
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: B. longumExperimental Treatment1 Intervention
Participants will be instructed to consume the capsule containing the live B. longum strain.
Group II: PlaceboPlacebo Group1 Intervention
Participants will be instructed to consume the placebo capsule without any live bacteria.

Find a Location

Who is running the clinical trial?

Morinaga Milk Industry Co., LTDLead Sponsor
5 Previous Clinical Trials
891 Total Patients Enrolled
Stacey BoettoPrincipal InvestigatorSTTI
~48 spots leftby Aug 2025
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