RecruitingNot ApplicableNCT05321758

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

Repeated and Multiple Fecal Microbiota Transplantations Plus Partial Enteral Nutrition as the First-line Treatment in Active Pediatric Crohn's Disease


Sponsor

Tongji Hospital

Enrollment

50 participants

Start Date

Mar 22, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 2 YearsMax Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether fecal microbiota transplantation (FMT) — transplanting gut bacteria from a healthy donor — can be used as the first treatment for a new diagnosis of Crohn's disease, before starting standard medications. **You may be eligible if...** - You have a new diagnosis of Crohn's disease (inflammatory bowel disease) - You have not yet started standard medication for Crohn's - You are willing to undergo FMT procedure - You are 18 or older (or pediatric with parental consent depending on protocol) **You may NOT be eligible if...** - You have severe complications requiring immediate surgery - You are severely immunocompromised - You have had prior bowel surgery affecting the study area Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALFecal Microbiota Transplantation

In the induction stage of CD, FMT was given 1-3 courses, 3-6 times per course.

DRUGImmunosuppressive Agents

hormones, azathioprine, thalidomide


Locations(1)

Tongji Hospital

Wuhan, Hubei, China

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NCT05321758


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