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
Sex
ALL
Min age
2 Years
Max age
16 Years
Healthy volunteers
Accepted
Inclusion Criteria:
age of older than 2 years and younger than 16 years with no genetic diseases; newly diagnosed with mild-to-moderate CD ( defined by the PCDAI of \>10 and ≤40, and SES-CD of \>3); Subjects with no change in medication or dose at least 1 week prior to transplantation; agree to received regularly colonoscopy
Exclusion Criteria:
patients who were treated with corticosteroids, methotrexate, thiopurines, and anti-TNF agents as their first-line treatment
Primary outcome measure(s)
Clinical remission — 8-12 weeks after FMT Clinical remission defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score≤10
Endoscopic remission — 8-12 weeks after FMT Endoscopic remission defined by a Simple Endoscopic Score for CD （SES-CD) ≤ 2
Mucosal healing — 8-12 weeks after FMT Mucosal healing defined as SES-CD = 0
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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