Radiation Induced Proctitis
Conditions
Keywords
fecal microbiota transplantation, rectal bleeding, radiation proctitis
Brief summary
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
BIOLOGICALFecal 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.
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with mild rectal bleeding (grade 0-1) | At the time of 12 weeks since the start of treatment | The symptom of rectal bleeding will be assessed by LENT-SOMA scales |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with mild rectal bleeding (grade 0-1) | At the time of 24 weeks since the start of treatment | The symptom of rectal bleeding will be assessed by LENT-SOMA scales |
| Number of participants with improved colonoscopic findings | At the time of 12 and 24 weeks since the start of treatment | The colonoscopic findings will be assessed by the Vienna Rectoscopy Score. |
Countries
China
Contacts
Primary ContactQiyuan Qin, M.D.
Outcome results
None listed