Probiotics for Constipation Relief in Adults

NCT07507955 · tracked via the Priya Life Science China tracker

Sponsor

Wecare Probiotics Co., Ltd

Phase

Not applicable

Started

2026-06-10

Last updated

2026-06-09

Condition(s) studied

Functional Constipation

Investigational drug(s) / intervention(s)

ProbioticMaltodextrinHigh-activity probiotic group

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.

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.

High-activity probiotic group: BLa36 will be administered orally once daily for 8 weeks. Follow-up assessments will be conducted at Week 0, Week 4, and Week 8.

Study summary

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 8 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

Improvement of constipation symptoms — 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).

Trial sites (1)

Facility	City	Region	Status
Suzhou Ninth People's Hospital	Suzhou	Jiangsu

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07507955 on ClinicalTrials.gov ↗ ← All trials in China