Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06776029

Fecal Microbiota Transplantation for Radiation-Induced Proctopathy

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Radiation Induced Proctitis Digestive System Diseases Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location status: Recruiting

Location contact

Qiyuan Qin, M.D., Ph.D.

CONTACT

[email protected]

86-20-38254052

Qiyuan Qin, M.D., Ph.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fecal Microbiota Transplantation Capsule

Biological

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.

Primary outcomes

  1. Number of participants with mild rectal bleeding (grade 0-1)

    Time frame: At the time of 12 weeks since the start of treatment

    The symptom of rectal bleeding will be assessed by LENT-SOMA scales

Secondary outcomes

  1. Number of participants with mild rectal bleeding (grade 0-1)

    Time frame: At the time of 24 weeks since the start of treatment

    The symptom of rectal bleeding will be assessed by LENT-SOMA scales

  2. Number of participants with improved colonoscopic findings

    Time frame: At the time of 12 and 24 weeks since the start of treatment

    The colonoscopic findings will be assessed by the Vienna Rectoscopy Score.

Study contacts

Contact information is provided by the study sponsor or research team.

Qiyuan Qin, M.D.

CONTACT

[email protected]

86-20-38254052

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Registry information

Official study title

A Prospective, Single-Arm Trial of Fecal Microbiota Transplantation for Hemorrhagic Radiation-Induced Rectal Injury

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 15, 2025
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.