Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07331688

CMTS0515-auWMT for Radiation Enteritis

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Radiation Enteritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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

Nanjing, Jiangsu, 210011, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

CMTS0515-augmented washed microbiota transplantation

Other

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

washed microbiota transplantation

Other

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

Primary outcomes

  1. The clinical response rate after treatment

    Time frame: 1 week, 4 weeks and 8 weeks

    Radiation Therapy Oncology Group (RTOG) scores

Secondary outcomes

  1. Scores of gastrointestinal symptoms

    Time frame: 1 week, 4 weeks and 8 weeks

    Gastrointestinal symptoms will be evaluated according to NCI-CTC 5.0

  2. Stool frequency and consistency

    Time frame: 1 week, 4 weeks and 8 weeks

    Stool frequency and consistency will be evaluated according to The Bristol Stool Form Scale (BSFS)

Sponsors and collaborators

Lead sponsor

The Second Hospital of Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Jan 12, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.