NCT07331688

CMTS0515-auWMT for Radiation Enteritis

CMTS0515 - Augmented Washed Microbiota Transplantation Versus Washed Microbiota Transplantation in Radiation Enteritis: A Randomized, Double-Blind, Non-inferiority Trial

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: The Second Hospital of Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized controlled trial to explore the exploring the non-inferiority of CMTS0515-augmented WMT compared to WMT.

Detailed description

At least 60 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 experimental group (CMTS0515-augmented WMT) and the control group (WMT). 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

• Radiation Enteritis

Interventions

Type	Name	Description
OTHER	CMTS0515-augmented washed microbiota transplantation	Lyophilized CMTS0515 is added to washed microbiota suspension and administered via mid-gut or colonic transendoscopic enteral tube.
OTHER	Washed Microbiota Transplantation	Washed microbiota suspension delivered through mid-gut and lower-gut transendoscopic enteral tube.

Timeline

• Start date: 2025-12-08
• Primary completion: 2030-11-30
• Completion: 2030-12-31
• First posted: 2026-01-12
• Last updated: 2026-01-12

Locations

1 site across 1 country: China