Fecal Microbiota Transplantation for Radiation-Induced Proctopathy
NCT ID: NCT06776029
Last Updated: 2025-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
20 participants
INTERVENTIONAL
2025-02-01
2026-06-30
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Fecal Microbiota Transplantation
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.
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.
Interventions
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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 Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Sixth Affiliated Hospital, Sun Yat-sen University
OTHER
Responsible Party
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Locations
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The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CRP202401
Identifier Type: -
Identifier Source: org_study_id
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