Fecal microbiota transplantation for children with ulcerative colitis
Repeated and Multiple Fecal Microbiota Transplantations in Active Pediatric Ulcerative Colitis (UC)
This study is testing if a treatment that combines fecal microbiota transplantation and special nutrition can help children with ulcerative colitis who haven't responded to regular treatments or those who are newly diagnosed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 2 Years to 16 Years |
| Sex | All |
| Sponsor | Tongji Hospital Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Wuhan) |
| Trial ID | NCT05679622 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy and safety of fecal microbiota transplantation (FMT) combined with partial enteral nutrition (PEN) in treating pediatric patients with refractory ulcerative colitis (UC) and as a first-line therapy for active UC. The trial includes two groups: one for children who have not responded to conventional treatments and another for those newly diagnosed with mild-to-moderate UC. Participants will receive FMT and PEN while continuing standard therapy, with the aim of gradually reducing conventional drug therapy. The study seeks to determine if this combined approach can improve clinical outcomes in these young patients.
Who should consider this trial
Good fit: Ideal candidates are children aged 2 to 16 years with mild-to-moderate ulcerative colitis, either newly diagnosed or refractory to conventional treatments.
Not a fit: Patients who have previously received certain first-line treatments or have contraindications to fecal microbiota transplantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for managing pediatric ulcerative colitis, particularly for those who have not responded to standard therapies.
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 in ulcerative colitis.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: age of older than 2 years and younger than 16 years with no genetic diseases; as a first-line treatment group for UC, newly diagnosed with mild-to-moderate UC (defined by the PUCAI of \>10 and≤64); In the refractory ulcerative colitis group, all refractory pediatric with mild-to-moderate UC (defined by the PUCAI of \>10 and≤64) defined by children who failed conventional treatment (hormone, immunosuppressant, biologics); agree to received regularly colonoscopy Exclusion Criteria: Children who were treated by PEN (80%) less than 8 weeks; As a first-line treatment group for UC, patients who were treated with corticosteroids, methotrexate, thiopurines, and anti-TNF agents as their first-line treatment; 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
- Tongji Hospital — Wuhan, China (Recruiting)
Study contacts
- Study coordinator: Biao Zou
- Email: 464021552@qq.com
- Phone: +8685726753
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.