Actively Recruiting
Fecal Microbiota Transplantation for Radiation-Induced Proctopathy
Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2025-03-10
20
Participants Needed
1
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Fecal Microbiota Transplantation for Radiation-Induced Proctopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old
- Completed pelvic radiotherapy at least 3 months before joining the study
- No evidence of tumor recurrence or metastasis
- Rectal bleeding with grade 2 to 4 according to LENT-SOMA scales
- Colonoscopy showing congested rectal mucosa or telangiectasia
- Poor response to supportive care or hemoglobin level of 70 g/L or less in the past 3 months
You will not qualify if you...
- Having acute or chronic infectious diseases
- Having serious systemic diseases
- Known allergies to any parts of the study medication
- Colonoscopy showing rectal ulceration larger than 1 cm², fistula, stricture, or necrosis
- Late complications related to pelvic radiation injury
- Having other bleeding or clotting disorders
- Previous surgery removing part of the rectum
- Bowel obstruction or perforation needing surgery
- Having cognitive or psychological disorders
- Any condition preventing safe administration of FMT
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
Q
Qiyuan Qin, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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