CMTS0515-auWMT for Radiation Enteritis

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Radiation Enteritis
• Intervention / Treatment: Other: CMTS0515-augmented washed microbiota transplantation; Other: Washed Microbiota Transplantation

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210011
      • Department of Microbiota Medicine & Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Histopathologically confirmed diagnosis of abdominal or pelvic cancer;
2. Completion of at least one entire course of radiation therapy;
3. Age ≥18 years at the time of cancer diagnosis.

Exclusion Criteria:

1. Absence of intestinal symptoms or transient intestinal symptoms;
2. Radiation treatment involving areas outside the abdomen and pelvis;
3. Diagnosis of antibiotic-associated diarrhea or use of antibiotics within four weeks before enrollment;
4. Presence of intestinal comorbidities, including inflammatory bowel disease or pseudomembranous colitis;
5. Presence of severe conditions rendering the patient unsuitable for inclusion;
6. Experience of bowel surgery for RE-associated fistula.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CMTS0515-augmented washed microbiota transplantation; Patients undergo CMTS0515-augmented washed microbiota transplantation once a day for three consecutive days.	Other: CMTS0515-augmented washed microbiota transplantation; Lyophilized CMTS0515 is added to washed microbiota suspension and administered via mid-gut or colonic transendoscopic enteral tube.
Active Comparator: washed microbiota transplantation; Patients undergo washed microbiota transplantation once a day for three consecutive days.	Other: Washed Microbiota Transplantation; Washed microbiota suspension delivered through mid-gut and lower-gut transendoscopic enteral tube.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The clinical response rate after treatment	Radiation Therapy Oncology Group (RTOG) scores	1 week, 4 weeks and 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scores of gastrointestinal symptoms	Gastrointestinal symptoms will be evaluated according to NCI-CTC 5.0	1 week, 4 weeks and 8 weeks
Stool frequency and consistency	Stool frequency and consistency will be evaluated according to The Bristol Stool Form Scale (BSFS)	1 week, 4 weeks and 8 weeks

Collaborators and Investigators

• Sponsor: The Second Hospital of Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2025
• Primary Completion (Estimated): November 30, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: December 29, 2025
• First Submitted That Met QC Criteria: December 29, 2025
• First Posted (Estimated): January 12, 2026

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Fecal Microbiota Transplantation; Randomized Controlled Trial; Radiotherapy; Radiation Enteritis; Washed Microbiota Transplantation
• Other Study ID Numbers: WMT-CMTS0515-RE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No