Actively Recruiting
Fecal Microbiota Transplantation in Pediatric Crohn's Disease
Led by Biao Zou · Updated on 2024-11-04
40
Participants Needed
1
Research Sites
218 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Fecal Microbiota Transplantation in Pediatric Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 2 and 16 years without genetic diseases
- Diagnosed with mild-to-moderate Crohn's disease
- Pediatric Crohn's disease activity index (PCDAI) greater than 10 and less than or equal to 40
- Simple Endoscopic Score for Crohn's Disease (SES-CD) greater than 3
- Refractory Crohn's disease defined as lack of response to standard treatments including steroids, immunosuppressants, and biologics
You will not qualify if you...
- Treatment with partial enteral nutrition (PEN) less than 8 weeks
- Follow-up shorter than 3 months
- Known contraindications to all FMT infusion methods (nasoduodenal tube insertion, oesophago-gastro-duodenoscopy, enteroscopy, colonoscopy, enema, fecal capsule)
- Unwillingness to provide informed consent or assent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tongji Hospital
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
B
Biao Zou, doctor
CONTACT
S
Sainan Shu, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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