Fecal microbiota transplantation for children with Crohn's disease
Repeated and Periodic Fecal Microbiota Transplantation in Children With Active and Refractory Crohn's Disease
This study is testing if a new treatment using fecal microbiota transplantation can help children aged 2-16 with tough-to-treat Crohn's disease feel better and improve their gut health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 2 Years to 16 Years |
| Sex | All |
| Sponsor | Tongji Hospital Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT05321745 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and effectiveness of fecal microbiota transplantation (FMT) combined with partial enteral nutrition (PEN) in children aged 2-16 years suffering from refractory Crohn's disease. The approach involves administering multiple courses of FMT alongside standard therapy, with the goal of improving gut health and managing symptoms. Participants will receive FMT 1-2 times per course, with maintenance treatments every three months, while gradually reducing conventional drug therapy. The study focuses on children who have not responded to standard treatments such as steroids and immunomodulators.
Who should consider this trial
Good fit: Ideal candidates are children aged 2-16 years with mild-to-moderate refractory Crohn's disease who have failed standard treatments.
Not a fit: Patients with genetic diseases or those who have contraindications to FMT procedures will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for children with refractory Crohn's disease who have not benefited from conventional therapies.
How similar studies have performed: Other studies have shown promising results with fecal microbiota transplantation in gastrointestinal disorders, suggesting potential success for this approach in Crohn's disease.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Wuhan, Hubei
- Tongji Hospital — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Biao Zou, doctor
- Email: 464021552@qq.com
- Phone: 027-83663594
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.