Fecal Microbiota Transplantation for Radiation-Induced Proctopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fecal Microbiota Transplantation Capsule.
- Who it may be relevant to
- Registry conditions: Radiation Induced Proctitis. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective, Single-Arm Trial of Fecal Microbiota Transplantation for Hemorrhagic Radiation-Induced Rectal Injury
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.
Interventions
- Biological 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.
Primary outcome measures
- Number of participants with mild rectal bleeding (grade 0-1) [Time frame: At the time of 12 weeks since the start of treatment]
Secondary outcome measures (2)
- Number of participants with mild rectal bleeding (grade 0-1) [Time frame: At the time of 24 weeks since the start of treatment]
- Number of participants with improved colonoscopic findings [Time frame: At the time of 12 and 24 weeks since the start of treatment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Sixth Affiliated Hospital of Sun Yat-sen University — Guangzhou
Identifiers
NCT: NCT06776029 · CRP202401