Fecal Microbiota Transplantation for Radiation-Induced Proctopathy

Sun Yat-sen University

Status and phase: Enrolling; Phase 2

Conditions: Radiation Induced Proctitis

Treatments: Biological: Fecal Microbiota Transplantation Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT06776029

CRP202401

Details and patient eligibility

About

The goal of this single-arm trial is to learn if Fecal Microbiota Transplantation (FMT) works to treat hemorrhagic radiation-induced proctopathy. The main questions it aims to answer are:

• Dose FMT alleviate the symptom of severe rectal bleeding?
• Dose FMT improve the endoscopic findings of proctopathy?

Participants will:

• Take fecal microbiota capsules by 8 sessions over a 12-week period.
• Visit the clinic once every 4 weeks for checkups and tests.
• Keep a diary of their symptoms and the number of times they use other supportive care.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: 18-75 years old
• At least 3 months since the completion of pelvic radiotherapy
• No evidence of tumor recurrence or metastasis
• Rectal bleeding with grade 2-4 by LENT-SOMA scales
• Colonoscopy indicating rectal congested mucosa or telangiectasia
• Poor response to supportive care, or hemoglobin level less than or equal to 70 g/L in the past 3 months

Exclusion criteria

• Acute or chronic infectious diseases
• Serious systemic diseases
• Known allergies to any components of the study medication
• Colonoscopy indicating rectal ulceration (>1cm2), fistula, stricture, or necrosis
• Late complications related to pelvic radiation injury
• Other hemorrhagic or coagulation disorders
• Previous rectal resection
• Bowel obstruction or perforation that require surgery
• Cognitive or psychological disorder
• Contraindications to FMT administration

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Fecal Microbiota Transplantation

Experimental group

Description:

Fecal microbiota capsules are given by 8 sessions over a 12-week period, with the initial 3 sessions every other day in the first week and the subsequent sessions every two weeks. The FMT regimen involves oral intake of 40 capsules per session. The best supportive care is performed when necessary, including oral medicine, enema, blood transfusion, and endoscopic procedures.

Treatment:

Biological: Fecal Microbiota Transplantation Capsule