Fecal Microbiota Transplantation in Pediatric Crohn's Disease

Recruiting now · Not applicable

Conditions studied: Crohn Disease

In brief

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

Key facts

Study ID

NCT05321745

Run by

Biao Zou

People needed

40

Starts

2022-03-22

Expected to finish

2027-05-31

Last updated by the study team

2026-07-10

Who can join

Age: 2 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 2-16 years and without genetic diseases; All refractory pediatric with mild-to-moderate CD; Mild-to-moderate CD, defined by the pediatric Crohn's disease activity index (PCDAI) >10 and ≤40 and Simple Endoscopic Score for CD (SES-CD) > 3 were enrolled in the study; refractory CD, defined by children who failed conventional treatment (hormone, immunosuppressant, biologics)
• Exclusion Criteria Children who were treated by PEN (80%) less than 8 weeks; follow up less than 3 months; known contraindication to all FMT infusion method such as nasoduodenal tube insertion, oesophago-gastro-duodenoscopy (OGD), enteroscopy, colonoscopy, enema and Fecal capsule; unwilling to give informed consent/assent

Where it is running

• Tongji Hospital — Wuhan, Hubei, China (enrolling)

Full record on ClinicalTrials.gov

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