Status:
RECRUITING
Fecal Microbiota Transplantation in Pediatric Crohn's Disease
Lead Sponsor:
Biao Zou
Conditions:
Crohn Disease
Eligibility:
All Genders
2-16 years
Phase:
NA
Brief 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 convention...
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
- Inclusion Criteria:
- 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)
- Exclusion Criteria Children who were treated by PEN (80%) less than 8 weeks; follow up less than 3 months; known contraindication to all FMT infusion method such as nasoduodenal tube insertion, oesophago-gastro-duodenoscopy (OGD), enteroscopy, colonoscopy, enema and Fecal capsule; unwilling to give informed consent/assent
Exclusion
Key Trial Info
Start Date :
March 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05321745
Start Date
March 22 2022
End Date
May 31 2026
Last Update
November 4 2024
Active Locations (1)
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1
Tongji Hospital
Wuhan, Hubei, China, 430030