Actively Recruiting

Phase Not Applicable
Age: 2Years - 16Years
All Genders
NCT05321745

Fecal Microbiota Transplantation in Pediatric Crohn's Disease

Led by Biao Zou · Updated on 2024-11-04

40

Participants Needed

1

Research Sites

218 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study will test the safety and effectiveness of fecal microbiota transplantation (FMT) plus partial enteral nutrition (PEN) in refractory pediatric Crohn's disease (CD) who have failed conventional treatment

CONDITIONS

Official Title

Fecal Microbiota Transplantation in Pediatric Crohn's Disease

Who Can Participate

Age: 2Years - 16Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 2 and 16 years without genetic diseases
  • Diagnosed with mild-to-moderate Crohn's disease
  • Pediatric Crohn's disease activity index (PCDAI) greater than 10 and less than or equal to 40
  • Simple Endoscopic Score for Crohn's Disease (SES-CD) greater than 3
  • Refractory Crohn's disease defined as lack of response to standard treatments including steroids, immunosuppressants, and biologics
Not Eligible

You will not qualify if you...

  • Treatment with partial enteral nutrition (PEN) less than 8 weeks
  • Follow-up shorter than 3 months
  • Known contraindications to all FMT infusion methods (nasoduodenal tube insertion, oesophago-gastro-duodenoscopy, enteroscopy, colonoscopy, enema, fecal capsule)
  • Unwillingness to provide informed consent or assent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Tongji Hospital

Wuhan, Hubei, China, 430030

Actively Recruiting

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Research Team

B

Biao Zou, doctor

CONTACT

S

Sainan Shu, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Fecal Microbiota Transplantation in Pediatric Crohn's Disease | DecenTrialz