Recruiting

Fecal Microbiota Transplantation for Hemorrhagic Radiation-Induced Rectal Injury

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What is being tested

Fecal Microbiota Transplantation Capsule

Biological
Who is being recruted

Digestive System Diseases+3

+ Gastrointestinal Diseases

+ Hemorrhage

From 18 to 75 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: February 2025
See protocol details

Summary

Principal SponsorSixth Affiliated Hospital, Sun Yat-sen University
Study ContactQiyuan Qin, M.D.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2025

Actual date on which the first participant was enrolled.

This clinical trial is designed to investigate if Fecal Microbiota Transplantation (FMT) can effectively treat hemorrhagic radiation-induced rectal injury, a condition that causes severe rectal bleeding due to radiation therapy. The study focuses on adults who experience this type of injury as a result of cancer treatment. By possibly reducing bleeding and improving the condition of the rectum as seen through an endoscopic examination, this study aims to offer a new treatment option for those suffering from this painful and challenging side effect. Participants in the study will take fecal microbiota in capsule form, administered over eight sessions during a 12-week period. They will visit the clinic every four weeks to undergo checkups and tests, ensuring that the treatment is working and monitoring any side effects. Participants will also keep a diary of their symptoms and note any other supportive care they use, helping researchers understand how FMT affects their condition and quality of life.

Official TitleA Prospective, Single-Arm Trial of Fecal Microbiota Transplantation for Hemorrhagic Radiation-Induced Rectal Injury
NCT06776029
Principal SponsorSixth Affiliated Hospital, Sun Yat-sen University
Study ContactQiyuan Qin, M.D.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesGastrointestinal DiseasesHemorrhageGastrointestinal HemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Criteria

6 inclusion criteria required to participate
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
Show More Criteria
10 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, ChinaOpen The Sixth Affiliated Hospital of Sun Yat-sen University in Google Maps
Recruiting
One Study Center