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Recruiting NCT05321758
Fecal Microbiota Transplantation as the First-line Treatment in Active Pediatric Crohn's Disease
Trial Parameters
Condition Crohn Disease
Sponsor Tongji Hospital
Study Type INTERVENTIONAL
Phase N/A
Enrollment 50
Sex ALL
Min Age 2 Years
Max Age 16 Years
Start Date 2020-03-22
Completion 2027-06-30
Interventions
Fecal Microbiota TransplantationImmunosuppressive Agents
Brief 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 Criteria
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
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