Probiotics for Constipation Relief in Adults

March 27, 2026 updated by: Wecare Probiotics Co., Ltd.

Efficacy and Safety of Bifidobacterium Animalis Subsp. Lactis BLa36 on Gastrointestinal Function, Inflammatory and Immune Responses, and Gut Microbiota in Adults With Functional Constipation: A Randomized, Double-Blind, Placebo-Controlled Trial

This study aims to evaluate the efficacy and safety of Bifidobacterium animalis subsp. lactis BLa36 in adults with functional constipation. In this randomized, double-blind, placebo-controlled trial, participants will receive BLa36 supplementation or placebo for 4 weeks. Clinical outcomes will be assessed using validated gastrointestinal symptom scales, stool characteristics, and quality-of-life measures. In addition, changes in inflammatory and immune markers, gut microbiota composition, metabolic indicators, and gut-brain axis-related parameters will be evaluated to comprehensively determine the effects of BLa36 on intestinal function and overall health.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215000
        • Suzhou Ninth People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Adults aged 18-65 years;
  2. Individuals diagnosed with constipation, defined as fewer than 3 bowel movements per week and/or Bristol Stool Form Scale (BSFS) types 1-2;
  3. Able and willing to comply with all study procedures and complete the study;
  4. Provided written informed consent prior to participation;
  5. Participants (including males) must have no intention of conception from 14 days before screening until 6 months after study completion and agree to use effective contraception.

Exclusion Criteria:

  1. Recent use of products with similar effects that may interfere with study outcomes; Significant dietary changes during the study period;
  2. History of severe allergy or immunodeficiency;
  3. Pregnant or breastfeeding women, or those planning pregnancy;
  4. Presence of serious systemic diseases (e.g., cardiovascular, pulmonary, hepatic, renal, endocrine, or malignant conditions);
  5. Use of antibiotics within the past 2 weeks;
  6. Individuals with severe psychiatric or neurological disorders;
  7. Poor compliance, including failure to take the study product or attend scheduled visits;
  8. Any other condition deemed unsuitable by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotic group
Participants in this group will receive Bifidobacterium animalis subsp. lactis BLa36 at a dose of 3 g per sachet, administered once daily for 8 weeks.
Dietary supplement: Probiotic
BLa36 will be administered orally once daily for 8 weeks. Follow-up assessments will be conducted at Week 0, Week 4, and Week 8.
Placebo Comparator: Placebo group
Participants in this group will receive a placebo containing maltodextrin (3 g per sachet), administered once daily for 8 weeks, matched in appearance and administration to the active product.
Dietary supplement: Maltodextrin
Maltodextrin will be administered orally once daily for 8 weeks. Follow-up assessments will be conducted at Week 0, Week 4, and Week 8.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of constipation symptoms
Time Frame: 8 weeks
Improvement in constipation will be evaluated using the Bristol Stool Form Scale (BSFS), with particular focus on changes in stool form from type 1-2 (hard stools/constipation) toward type 3-4 (normal stool consistency).
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wecare Probiotics Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

January 20, 2027

Study Registration Dates

First Submitted

March 27, 2026

First Submitted That Met QC Criteria

March 27, 2026

First Posted (Actual)

April 2, 2026

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WK20260328

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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