Actively Recruiting

Phase Not Applicable
Age: 2Years - 16Years
All Genders
Healthy Volunteers
NCT05321758

Fecal Microbiota Transplantation as the First-line Treatment in Active Pediatric Crohn's Disease

Led by Tongji Hospital · Updated on 2025-04-11

50

Participants Needed

1

Research Sites

379 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

To explore the safety and effectiveness of repeated and multiple fecal microbiota transplantations (FMTs) plus partial enteral nutrition (PEN) as a first-line treatment for active Crohn's disease (CD) in children.

CONDITIONS

Official Title

Fecal Microbiota Transplantation as the First-line Treatment in Active Pediatric Crohn's Disease

Who Can Participate

Age: 2Years - 16Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age older than 2 years and younger than 16 years with no genetic diseases
  • Newly diagnosed with mild-to-moderate Crohn's disease (PCDAI >10 and 40, SES-CD >3)
  • No change in medication or dose at least 1 week prior to transplantation
  • Agree to receive regular colonoscopy
Not Eligible

You will not qualify if you...

  • Treated with corticosteroids, methotrexate, thiopurines, or anti-TNF agents as first-line treatment

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, MD

CONTACT

S

Sainan Shu, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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