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Clinical Trials in China / NCT05321745
Recruiting Not applicable

Fecal Microbiota Transplantation in Pediatric Crohn's Disease

NCT05321745 · tracked via the Priya Life Science China tracker
Sponsor
Biao Zou
Phase
Not applicable
Started
2022-03-22
Last updated
2026-07-10

Condition(s) studied

Crohn Disease

Investigational drug(s) / intervention(s)

Standardized FMT

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

Trial sites (1)

FacilityCityRegionStatus
Tongji Hospital Wuhan Hubei Recruiting

More Biao Zou trials in China

Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis (UC) Recruiting

Other trials for the same condition

Prospective Cohort Establishment and Clinical Observation of Children With Crohn's Disease Active, not recruiting
Efficacy and Safety of CDED With Anti-TNF-α Biologics in Crohn's Disease Starting soon
Comparing Endoscopic Strictureplasty vs. Balloon Dilation in Crohn's Disease Strictures Recruiting
Effect of Acupuncture on Mild to Moderate Active Crohn's Disease Recruiting
A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease Recruiting
Official registry record

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.

View NCT05321745 on ClinicalTrials.gov ↗ ← All trials in China