Fecal Microbiota Transplantation as the First-line Treatment in Active Pediatric Crohn's Disease
Recruiting · NCT05321758 · Interventional (participants receive a specific treatment) · Lead sponsor: Tongji Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Fecal Microbiota TransplantationImmunosuppressive Agents
What this trial is about
To explore the safety and effectiveness of repeated and multiple fecal microbiota transplantations (FMTs) plus partial enteral nutrition (PEN) as a first-line treatment for active Crohn's disease (CD) in children.
Who can take part
Age range
2 Years to 16 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- age of older than 2 years and younger than 16 years with no genetic diseases; newly diagnosed with mild-to-moderate CD ( defined by the PCDAI of \>10 and ≤40, and SES-CD of \>3); Subjects with no change in medication or dose at least 1 week prior to transplantation; agree to received regularly colonoscopy
Exclusion criteria
- patients who were treated with corticosteroids, methotrexate, thiopurines, and anti-TNF agents as their first-line treatment
Where it is running
1 location listed.
- Tongji Hospital - Wuhan, Hubei, China