Radiation Induced ProctitisPhase 2NCT06776029
Fecal Microbiota Transplantation for Radiation-Induced Proctopathy
A Phase 2 study testing Fecal Microbiota Transplantation Capsule in people with Radiation Induced Proctitis, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Radiation Induced Proctitis
- What is being tested?
- Fecal Microbiota Transplantation Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2025to 30 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Previous rectal resection
- Bowel obstruction or perforation that require surgery
- Cognitive or psychological disorder
- Contraindications to FMT administration
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
Qiyuan Qin, M.D., Ph.D., 86-20-38254052, qinqy3@mail.sysu.edu.cn
Qiyuan Qin, M.D., Ph.D.
About this study
Official title: A Prospective, Single-Arm Trial of Fecal Microbiota Transplantation for Hemorrhagic Radiation-Induced Rectal Injury
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.
- Conditions
- Radiation Induced Proctitis
- Being tested
- Fecal Microbiota Transplantation Capsule
- Keywords
- fecal microbiota transplantation, rectal bleeding, radiation proctitis
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota Transplantation CapsuleBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Fecal Microbiota Transplantation | 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. Receives: Biological: Fecal Microbiota Transplantation Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with mild rectal bleeding (grade 0-1)
The symptom of rectal bleeding will be assessed by LENT-SOMA scales
Measured: At the time of 12 weeks since the start of treatment
Secondary outcomes (2)
Number of participants with mild rectal bleeding (grade 0-1)
The symptom of rectal bleeding will be assessed by LENT-SOMA scales
Measured: At the time of 24 weeks since the start of treatment
Number of participants with improved colonoscopic findings
The colonoscopic findings will be assessed by the Vienna Rectoscopy Score.
Measured: At the time of 12 and 24 weeks since the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start1 Feb 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation Induced ProctitisStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776029
- Sponsor's protocol ID
- CRP202401
- Status last verified
- Oct 2026
- First submitted
- 10 Jan 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm Trial of Fecal Microbiota Transplantation for Hemorrhagic Radiation-Induced Rectal Injury
- ClinicalTrials.gov ID
- NCT06776029
- Acronym / sponsor ID
- CRP202401
- Conditions
- Radiation Induced Proctitis
- Keywords
- fecal microbiota transplantation, rectal bleeding, radiation proctitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fecal Microbiota Transplantation | Experimental | Biological: Fecal Microbiota Transplantation CapsuleFecal 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal Microbiota Transplantation CapsuleFMT 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. | Biological | Fecal Microbiota Transplantation |
Primary outcome
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
2 secondary outcomes
Number of participants with mild rectal bleeding (grade 0-1)
Time frame: At the time of 24 weeks since the start of treatment
Number of participants with improved colonoscopic findings
Time frame: At the time of 12 and 24 weeks since the start of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fecal Microbiota Transplantation Capsule in people with Radiation Induced Proctitis, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiyuan Qin, M.D. (86-20-38254052, qinqy3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with mild rectal bleeding (grade 0-1) (time frame: At the time of 12 weeks since the start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.