RecruitingNot ApplicableNCT05321745
Fecal Microbiota Transplantation in Pediatric Crohn's Disease
Repeated and Periodic Fecal Microbiota Transplantation in Children With Active and Refractory Crohn's Disease
Sponsor
Biao Zou
Enrollment
40 participants
Start Date
Mar 22, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Min Age: 2 YearsMax Age: 16 Years
Inclusion Criteria1
- 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)
Interventions
OTHERStandardized FMT
Fecal microbiota transplantation of fresh bacteria from healthy donor to the whole colon
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05321745
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