Using fecal microbiota transplantation to treat active Crohn's disease in children
Repeated and Multiple Fecal Microbiota Transplantations Plus Partial Enteral Nutrition as the First-line Treatment in Active Pediatric Crohn's Disease
This study is testing whether a new treatment using fecal microbiota transplantation along with a special diet can help children with newly diagnosed Crohn's disease feel better compared to a traditional treatment with medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 2 Years to 16 Years |
| Sex | All |
| Sponsor | Tongji Hospital Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT05321758 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and effectiveness of repeated fecal microbiota transplantation (FMT) combined with partial enteral nutrition (PEN) as a first-line treatment for active Crohn's disease in pediatric patients. Participants aged 2 to 16 years with newly diagnosed mild-to-moderate Crohn's disease will be divided into two groups: one receiving FMT and PEN, and the other receiving PEN with immunosuppressive agents. The study aims to compare the therapeutic effects of these two approaches, with FMT administered through various routes including oral capsules and enemas. All patients will also receive a polymeric diet to support clinical remission.
Who should consider this trial
Good fit: Ideal candidates are children aged 2 to 16 years with newly diagnosed mild-to-moderate Crohn's disease.
Not a fit: Patients who have previously been treated with corticosteroids, methotrexate, thiopurines, or anti-TNF agents as their first-line treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel and effective treatment option for children suffering from active Crohn's disease.
How similar studies have performed: Other studies have shown promising results with fecal microbiota transplantation in treating gastrointestinal disorders, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Wuhan, Hubei
- Tongji Hospital — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Biao Zou, MD
- Email: 464021552@qq.com
- Phone: 15871365900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.