Using fecal microbiota transplantation to treat radiation-induced proctopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.