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Dietary Supplements to Treat Radiation-Induced Rectal Injury

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 7, 2026 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.
Trial flagged as At Risk
Primary completion moved at least 12 months later Sep 30, 2025 → Sep 30, 2026
See other at-risk trials from Sixth Affiliated Hospital, Sun Yat-sen University

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Sep 30, 2025 to Sep 30, 2026
    • Study completion pushed from Dec 31, 2025 to Dec 31, 2026
    v4
  2. Enrollment target: 20 to 33
    • Study sites: 2 to 1
    • Eligibility criteria shortened, about 4 words
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06776016
Lead Sponsor Sixth Affiliated Hospital, Sun Yat-sen University
Conditions
(from sponsor)		 Radiotherapy, Radiation Proctitis
Related terms Gastrointestinal Hemorrhage
Enrollment 33 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov