Fecal Microbiota Transplantation for Radiation-Induced Proctopathy

Phase 2RecruitingNCT06776029

Sixth Affiliated Hospital, Sun Yat-sen University20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Radiation Induced Proctitis

Interventions

Fecal Microbiota Transplantation Capsule

FMT is delivered via oral capsules. 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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of participants with mild rectal bleeding (grade 0-1)

The symptom of rectal bleeding will be assessed by LENT-SOMA scales

Time frame: At the time of 12 weeks since the start of treatment

Secondary Outcomes

Number of participants with mild rectal bleeding (grade 0-1)

The symptom of rectal bleeding will be assessed by LENT-SOMA scales

Time frame: At the time of 24 weeks since the start of treatment

Number of participants with improved colonoscopic findings

The colonoscopic findings will be assessed by the Vienna Rectoscopy Score.

Time frame: At the time of 12 and 24 weeks since the start of treatment