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NCT Number: NCT06776016

Dietary Supplements to Treat Radiation-Induced Rectal Injury

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.

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Key information

Conditions

Radiotherapy Digestive System Diseases Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Proctitis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Location status: Recruiting

Location contact

Lekun Fang, M.D.

CONTACT

[email protected]

+86-13560226002

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Butyrate

Dietary Supplement

Agent: The dietary supplement contains tributyrin, a pro-drug of butyrate. Method: Participants receive the supplement orally at a dose of 20 ml, 2-3 times daily, 12 weeks.

Primary outcomes

  1. Number of participants with alleviated rectal bleeding (degraded by 1 or more)

    Time frame: At the time of 12 weeks since the start of treatment

    The symptom of rectal bleeding will be assessed by LENT-SOMA scales

Secondary outcomes

  1. Number of participants with mild rectal bleeding (grade 0-1)

    Time frame: At the time of 24 weeks since the start of treatment

    The symptom of rectal bleeding will be assessed by LENT-SOMA scales

Study contacts

Contact information is provided by the study sponsor or research team.

Lekun Fang

CONTACT

[email protected]

+86-13560226002

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 15, 2025
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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