Actively Recruiting
Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis (UC)
Led by Biao Zou · Updated on 2024-11-04
30
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study included two topics: one was to test the efficacy and safety of fecal microbiota transplants plus partial enteral nutrition (PEN) in refractory pediatric UC where conventional therapy has failed, and the other was to explore the efficacy and safety of FMT plus PEN as first-line therapy for pediatric active UC
CONDITIONS
Official Title
Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis (UC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age older than 2 years and younger than 16 years with no genetic diseases
- Newly diagnosed with mild-to-moderate ulcerative colitis (PUCAI >10 and 4)
- Refractory pediatric ulcerative colitis with mild-to-moderate disease who failed conventional treatments (hormones, immunosuppressants, biologics)
- Agreement to receive regular colonoscopy exams
You will not qualify if you...
- Treated with partial enteral nutrition (80%) for less than 8 weeks
- Received corticosteroids, methotrexate, thiopurines, or anti-TNF agents as first-line treatment for ulcerative colitis
- Known contraindications to FMT infusion methods such as nasoduodenal tube insertion, endoscopy, colonoscopy, enema, or fecal capsule
- Unwilling 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, China, 430030
Actively Recruiting
Research Team
B
Biao Zou
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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