CMTS0515-auWMT for Radiation Enteritis

NCT07331688 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: WMT-CMTS0515-RE
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Radiation Enteritis

Keywords

Fecal Microbiota Transplantation; Washed Microbiota Transplantation; Radiotherapy; Radiation Enteritis; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• The clinical response rate after treatment

  Radiation Therapy Oncology Group (RTOG) scores

  1 week, 4 weeks and 8 weeks

Secondary Outcomes (2)

• Scores of gastrointestinal symptoms

  1 week, 4 weeks and 8 weeks

• Stool frequency and consistency

  1 week, 4 weeks and 8 weeks

Study Arms (2)

CMTS0515-augmented washed microbiota transplantation

EXPERIMENTAL

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

Other: CMTS0515-augmented washed microbiota transplantation

washed microbiota transplantation

ACTIVE COMPARATOR

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

Other: Washed Microbiota Transplantation

Interventions

CMTS0515-augmented washed microbiota transplantation OTHER

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

CMTS0515-augmented washed microbiota transplantation

Washed Microbiota Transplantation OTHER

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

washed microbiota transplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Experience of bowel surgery for RE-associated fistula.

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University: lead

Study Sites (1)

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

Nanjing, Jiangsu, 210011, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Gastroenterology

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 12, 2026
• Study Start: December 8, 2025
• Primary Completion (Estimated): November 30, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: January 12, 2026

Record last verified: 2025-12

Locations

CN (1)