Using fecal microbiota transplantation to treat radiation-induced proctopathy
A Prospective, Single-Arm Trial of Fecal Microbiota Transplantation for Hemorrhagic Radiation-Induced Rectal Injury
This study is testing if fecal microbiota transplantation can help people with severe rectal bleeding caused by radiation treatment feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06776029 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of fecal microbiota transplantation (FMT) in treating severe rectal bleeding caused by radiation-induced proctopathy. Participants will receive FMT capsules over eight sessions within a 12-week period and will attend clinic visits every four weeks for monitoring and assessments. The study will focus on whether FMT can alleviate symptoms and improve endoscopic findings related to proctopathy. Participants will also maintain a diary to track their symptoms and any additional supportive care used.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 who have experienced rectal bleeding after pelvic radiotherapy and have not responded well to other treatments.
Not a fit: Patients with acute or chronic infections, serious systemic diseases, or significant rectal complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce rectal bleeding and improve quality of life for patients suffering from radiation-induced proctopathy.
How similar studies have performed: While fecal microbiota transplantation has shown promise in other gastrointestinal conditions, this specific application for radiation-induced proctopathy is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Guangzhou, Guangdong
- The Sixth Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Qiyuan Qin, M.D.
- Email: qinqy3@mail.sysu.edu.cn
- Phone: 86-20-38254052
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.