Dietary Supplements to Treat Radiation-Induced Rectal Injury

A Prospective, Single-Arm, Single-Center Study of Dietary Supplements in the Treatment of Radiation-Induced Rectal Injury

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06776016

Enrollment

Registered

2025-01-15

Start date

2025-01-15

Completion date

2026-12-31

Last updated

2026-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiation Proctitis, Radiotherapy

Keywords

radiotherapy, radiation proctitis, tributyrin, rectal bleeding, butyrate

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTButyrate

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with alleviated rectal bleeding (degraded by 1 or more)	At the time of 12 weeks since the start of treatment	The symptom of rectal bleeding will be assessed by LENT-SOMA scales

Secondary

Measure	Time frame	Description
Number of participants with mild rectal bleeding (grade 0-1)	At the time of 24 weeks since the start of treatment	The symptom of rectal bleeding will be assessed by LENT-SOMA scales

Countries

China

Contacts

CONTACTLekun Fang

fanglk3@mail.sysu.edu.cn+86-13560226002

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 8, 2026