Fecal Microbiota Transplantation for Radiation-Induced Proctopathy
Recruiting
Phase 2
Interventional Study
Radiation Induced Proctitis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 20 (estimated)
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University · Other
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About This Trial
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.
*…
Trial Locations
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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 suppo…
Contacts