Status:
RECRUITING
Fecal Microbiota Transplantation as the First-line Treatment in Active Pediatric Crohn's Disease
Lead Sponsor:
Tongji Hospital
Conditions:
Crohn Disease
Eligibility:
All Genders
2-16 years
Phase:
NA
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)...
Detailed Description
Recent studies have suggested that gut imbalance and deregulation of immunological responses plays a pivotal role in the disease development of Crohn's disease (CD), and that FMT could be a useful tre...
Eligibility Criteria
Inclusion
- 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
- patients who were treated with corticosteroids, methotrexate, thiopurines, and anti-TNF agents as their first-line treatment
Key Trial Info
Start Date :
March 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05321758
Start Date
March 22 2020
End Date
June 30 2027
Last Update
April 11 2025
Active Locations (1)
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1
Tongji Hospital
Wuhan, Hubei, China, 430030