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Clinical Trials in China / NCT07331688
Active, not recruiting Phase 1/2

CMTS0515-auWMT for Radiation Enteritis

NCT07331688 · tracked via the Priya Life Science China tracker
Sponsor
The Second Hospital of Nanjing Medical University
Phase
Phase 1/2
Started
2025-12-08
Last updated
2026-01-12

Condition(s) studied

Radiation Enteritis

Investigational drug(s) / intervention(s)

CMTS0515-augmented washed microbiota transplantationWashed Microbiota Transplantation

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

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

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • The clinical response rate after treatment — 1 week, 4 weeks and 8 weeks
    Radiation Therapy Oncology Group (RTOG) scores

Trial sites (1)

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

More The Second Hospital of Nanjing Medical University trials in China

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Washed Microbiota Transplantation for Diabetic Gastroparesis Recruiting
Washed Microbiota Transplantation for Rhinitis Starting soon
Gut Oxygen Therapy for Ischemic-Hypoxic Bowel Disease Recruiting
Washed Microbiota Transplantation for Allergic Rhinitis Starting soon

Other trials for the same condition

Association Between Clinical Classification and Prognosis in Chronic Radiation Enteropathy Recruiting
Efficacy and Safety of Thalidomide Combined With Glutamine in the Treatment of Radiation Intestinal Injury. Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07331688 on ClinicalTrials.gov ↗ ← All trials in China