Using dietary supplements to treat rectal injury from radiation
Official title: A Prospective, Single-Arm, Single-Center Study of Dietary Supplements in the Treatment of Radiation-Induced Rectal Injury
Run by Sixth Affiliated Hospital, Sun Yat-sen University · NCT06776016 · Data updated 2026-11-12
This study is testing whether a dietary supplement called tributyrin can help people with chronic rectal injury from radiation feel better and improve their quality of life.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 33 (estimated) |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | January 15, 2025 |
| Main results expected | September 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | August 7, 2026 |
| Trial ID | NCT06776016 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-75 who have experienced rectal bleeding after pelvic radiotherapy and have no evidence of tumor recurrence.
✕Probably not a fit
Patients with serious systemic diseases, rectal ulcerations, or other significant gastrointestinal complications may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical study is a prospective, single-arm trial that evaluates the safety and efficacy of tributyrin as a dietary supplement for patients suffering from chronic radiation-induced rectal injury. The study aims to improve symptoms of rectal bleeding and enhance the quality of life by administering tributyrin and monitoring its effects through blood tests and non-invasive methods. Participants will be closely monitored to ensure their safety and comfort throughout the trial.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce rectal bleeding and improve the quality of life for patients with radiation-induced rectal injury.
How similar studies have gone: While this approach is novel in the context of radiation-induced rectal injury, other studies have explored the use of butyrate for gastrointestinal health with varying degrees of success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-75 years * At least 3 months since the completion of pelvic radiotherapy * No evidence of tumor recurrence or metastasis * Rectal bleeding with grade 1-2 by LENT-SOMA scales 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
Where it's running
-
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China Recruiting
Study contacts
- Study coordinator: Lekun Fang
- Email: fanglk3@mail.sysu.edu.cn
- Phone: +86-13560226002
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.