About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Butyrate