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CMTS0515-auWMT for Radiation Enteritis | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

CMTS0515-auWMT for Radiation Enteritis

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

NCT07331688•The Second Hospital of Nanjing Medical University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

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

Nanjing, Jiangsu, China

Key Dates

Start Date

December 8, 2025

Primary Completion Date

November 30, 2030

Completion Date

December 31, 2030

Last Updated

January 12, 2026

Enrollment

ESTIMATED participants

Conditions

Radiation Enteritis

Interventions

CMTS0515-augmented washed microbiota transplantation

OTHER

Washed Microbiota Transplantation

OTHER

Fecal Microbiota Transplantation for Radiation Enteritis

NCT03516461

Radiation Enteritis

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ENROLLING_BY_INVITATIONPHASE1/PHASE2

Gegen Qinlian Tang and Probiotics for Radiation Enteritis

NCT06836960

Acute Radiation Enteritis

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COMPLETEDNA

Preclinical Evaluation of Multimodal Therapeutic Strategies in Intestinal Irradiation and Inflammatory Bowel Disease From Organoids

NCT05425901

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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CMTS0515-auWMT for Radiation Enteritis

Inclusion Criteria

Exclusion Criteria

Fecal Microbiota Transplantation for Radiation Enteritis

Gegen Qinlian Tang and Probiotics for Radiation Enteritis

Preclinical Evaluation of Multimodal Therapeutic Strategies in Intestinal Irradiation and Inflammatory Bowel Disease From Organoids

Efficacy and Safety of Thalidomide Combined With Glutamine in the Treatment of Radiation Intestinal Injury.

Pentosan Polysulfate in Treating Patients With Gastrointestinal Disturbance Caused by Radiation Therapy

Octreotide in Preventing or Reducing Diarrhea in Patients Receiving Chemoradiotherapy for Anal or Rectal Cancer