NCT07507955

Probiotics for Constipation Relief in Adults

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Wecare Probiotics Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Functional Constipation

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2026-04-15
• Primary completion: 2026-11-30
• Completion: 2027-01-20
• First posted: 2026-04-02
• Last updated: 2026-04-02

Locations

1 site across 1 country: China