Fecal Microbiota Transplantation in Pediatric Crohn's Disease
Recruiting · NCT05321745 · Interventional (participants receive a specific treatment) · Lead sponsor: Biao Zou
View the official record on ClinicalTrials.gov →Interventions studied
Standardized FMT
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
Who can take part
Age range
2 Years to 16 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Tongji Hospital - Wuhan, Hubei, China