NCT06839599

CMTS4520-Assisted Washed Microbiota Transplantation for Chronic Diarrhoea in Adults

The Efficacy and Safety of CMTS4520-Assisted Washed Microbiota Transplantation for Chronic Diarrhoea in Adults： a Randomized, Double-Blind, Placebo-Controlled Trial.

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: The Second Hospital of Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized controlled trial to explore the efficacy and safety of CMTS4520 (Dietary Fiber Probiotics) assisted washed microbiota transplantation for patients with chronic diarhoea.

Detailed description

At least 100 subjects who meet all the inclusion criteria but do not meet any exclusion criteria will be enrolled in this study. They will be randomly assigned to the CMTS4520 group (dietary fiber probiotics capsules) and the control group (placebo) after receiving washed microbiota transplantation. Data of demographic characteristics, intestinal symptoms, medicine treatment usage and clinical outcomes will be collected. After treatment, they will enter the follow-up period for efficacy and safety evaluation.

Conditions

• Diarrhea

Interventions

Type	Name	Description
DRUG	CMTS4520 (dietary fiber probiotics)	CMTS4520 is a synbiotic formulation containing a standardized ratio of plant-derived prebiotics and clinically validated probiotic strains. Participants will receive 4 weeks of CMTS4520 daily for chronic diarrhoea.
DRUG	Placebo	Capsules with matching volume and consistent appearance to CMTS4520.

Timeline

• Start date: 2025-02-20
• Primary completion: 2030-01-01
• Completion: 2030-07-01
• First posted: 2025-02-21
• Last updated: 2025-02-21

Locations

1 site across 1 country: China