CMTS0515-auWMT for Radiation Enteritis

Phase 2Active Not RecruitingNCT07331688

The Second Hospital of Nanjing Medical University60 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Radiation Enteritis

Interventions

CMTS0515-augmented washed microbiota transplantationOTHER

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

Washed Microbiota TransplantationOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The clinical response rate after treatment

Radiation Therapy Oncology Group (RTOG) scores

Time frame: 1 week, 4 weeks and 8 weeks

Secondary Outcomes

Scores of gastrointestinal symptoms

Gastrointestinal symptoms will be evaluated according to NCI-CTC 5.0

Time frame: 1 week, 4 weeks and 8 weeks

Stool frequency and consistency

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

Time frame: 1 week, 4 weeks and 8 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.