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
Inclusion Criteria1
- 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 Criteria1
- patients who were treated with corticosteroids, methotrexate, thiopurines, and anti-TNF agents as their first-line treatment
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05321758
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