Standardized FMT: Fecal microbiota transplantation of fresh bacteria from healthy donor to the whole colon
Study 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
Sex
ALL
Min age
2 Years
Max age
16 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Clinical remission — 8-12 weeks after FMT Clinical remission defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score≤10
Endoscopic remission — 8-12 weeks after FMT Endoscopic remission defined by a Simple Endoscopic Score for CD （SES-CD) ≤ 2
Mucosal healing — 8-12 weeks after FMT Mucosal healing defined as SES-CD = 0
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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