CMTS0515-auWMT for Radiation Enteritis

NCT ID: NCT07331688

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-08
• Study Completion Date: 2030-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CMTS0515-augmented washed microbiota transplantation

Patients undergo CMTS0515-augmented washed microbiota transplantation once a day for three consecutive days.

Group Type: EXPERIMENTAL

CMTS0515-augmented washed microbiota transplantation

Intervention Type: OTHER

Lyophilized CMTS0515 is added to washed microbiota suspension and administered via mid-gut or colonic transendoscopic enteral tube.

washed microbiota transplantation

Patients undergo washed microbiota transplantation once a day for three consecutive days.

Group Type: ACTIVE_COMPARATOR

Washed Microbiota Transplantation

Intervention Type: OTHER

Washed microbiota suspension delivered through mid-gut and lower-gut transendoscopic enteral tube.

Interventions

CMTS0515-augmented washed microbiota transplantation

Lyophilized CMTS0515 is added to washed microbiota suspension and administered via mid-gut or colonic transendoscopic enteral tube.

Intervention Type: OTHER

Washed Microbiota Transplantation

Washed microbiota suspension delivered through mid-gut and lower-gut transendoscopic enteral tube.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second Hospital of Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Faming Zhang

Professor, Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

WMT-CMTS0515-RE

Identifier Type: -

Identifier Source: org_study_id