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Fecal Microbiota Transplantation for Radiation Enteritis

ConditionRadiation Enteritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorThe Second Hospital of Nanjing Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age ≥18 years old;

Radiation enteritis diagnosed by colonoscopy after finishing radiotherapy.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fecal Microbiota Transplantation (FMT)

    Procedure/Surgery

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

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Fecal Microbiota Transplantation (FMT)Experimental treatment 1 intervention
Group B: Basic treatmentNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Clinical response rate

The clinical response rate at 8 weeks after fmt treatment

Time frame
12 weeks

Secondary outcomes

1

Scores of gastrointestinal symptoms

Gastrointestinal symptoms will be evaluated according to NCI-CTC 5.0

Time frame
4, 8, 12 weeks
2

Change of toxicity grade

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

Time frame
4, 8, 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Second Hospital of Nanjing Medical University

Lead sponsor

Jiangxi Provincial Cancer Hospital

Collaborator

Source ClinicalTrials.gov
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