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NCT Number: NCT03516461

Fecal Microbiota Transplantation for Radiation Enteritis

Radiation enteritis is one of the most feared complications after abdominal or pelvic radiation therapy.The gut microbiota is considered to constitute a "microbial organ" which has pivotal roles in the intestinal diseases and body metabolism. Evidence from animal studies demonstrated the link between intestinal bacteria and radiation enteritis. This clinical trial aims to evaluate the efficacy and safety of fecal microbiota transplantation (FMT) for radiation enteritis.

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Key information

Conditions

Radiation Enteritis

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China

Location status: Recruiting

Location contact

Faming Zhang, MD, PhD

CONTACT

[email protected]

086-25-58509883

About this study

The present clinical trial aims to re-establish a gut functionality state of intestinal microbiota through fecal microbiota transplantation (FMT) for radiation enteritis (RE). FMT is the whole profile of fecal microbiota transplantation. At enrollment, "Shared Decision Making" intervention was applied to support patient involvement in making health decisions. Patients have opportunity to choose fecal microbiota transplantation (FMT). Patients will receive follow-up for at least 12 weeks. Blood test, endoscopy and questionnaire will be used to access participants at study start and at study completion. Fecal microbiota compositions, blood and urinary metabolic profiles of patients will be analyzed to assess associated microbial changes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age ≥18 years old;
  • Radiation enteritis diagnosed by colonoscopy after finishing radiotherapy.

Exclusion criteria

  • Patients who were pregnant or nursing;
  • Patients who were unable or unwilling to undergo a gastroscopy;
  • Patients who had gastrointestinal infection;
  • Patients with cardiopulmonary failure.

Treatment and study plan

Fecal microbiota transplantation (FMT)

Procedure

Fecal microbiota transplantation for patients via nasointestinal tube or gastroscopy or colonic TET tube

Other names: FMT

Primary outcomes

  1. Clinical response rate

    Time frame: 12 weeks

    The clinical response rate at 8 weeks after fmt treatment

Secondary outcomes

  1. Scores of gastrointestinal symptoms

    Time frame: 4, 8, 12 weeks

    Gastrointestinal symptoms will be evaluated according to NCI-CTC 5.0

  2. Change of toxicity grade

    Time frame: 4, 8, 12 weeks

    The change of toxicity grade according to the RTOG/EORTC toxicity scale at 4, 8, 12 weeks after FMT

Study contacts

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

Faming Zhang, MD; PHD

CONTACT

[email protected]

086-25-58509883

Sponsors and collaborators

Lead sponsor

The Second Hospital of Nanjing Medical University

Other

Collaborators

  • Jiangxi Provincial Cancer Hospital

Registry information

Official study title

Efficacy and Safety of Fecal Microbiota Transplantation in Radiation Enteritis

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
May 4, 2018
Registry last updated
Mar 30, 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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