Dietary Supplements to Treat Radiation-Induced Rectal Injury

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSixth Affiliated Hospital, Sun Yat-sen University

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

Treatment groups

33 Participants
are divided into 1 treatment group