A Phase 2 interventional study of Butyrate in Radiotherapy and Radiation Proctitis, sponsored by Sixth Affiliated Hospital, Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Sixth Affiliated Hospital, Sun Yat-sen University · Phase 2, Interventional, and Treatment
This clinical study is a prospective, single-arm, single-center trial aimed at assessing the safety and efficacy of tributyrin (TB) as dietary supplements in the treatment of chronic radiation-induced rectal injury (RRI). We hypothesize that these supplements will help improve rectal bleeding symptoms and elevate the quality of life for patients. The study will test whether the supplements can lower the LENT-SOMA scales of rectal bleeding and enhance overall patient health. Efficacy will be evaluated through blood tests and other non-invasive methods, ensuring patient safety and comfort throughout the study.
Exclusion Criteria:
Participants receive dietary supplements combined with supportive care.
Dietary Supplement: Butyrate
Agent: The dietary supplement contains tributyrin, a pro-drug of butyrate. Method: Participants receive the supplement orally at a dose of 1650 mg, 2-3 times daily, 12 weeks.
Number of participants with alleviated rectal bleeding (degraded by 1 or more)
The symptom of rectal bleeding will be assessed by LENT-SOMA scales
Time frame: At the time of 12 weeks since the start of treatment
Number of participants with mild rectal bleeding (grade 0-1)
The symptom of rectal bleeding will be assessed by LENT-SOMA scales
Time frame: At the time of 24 weeks since the start of treatment
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sixth Affiliated Hospital, Sun Yat-sen University