Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis (UC)
Patients and families with pediatric UC may be interested because the study tests FMT plus partial enteral nutrition as a potential new treatment approach for children who haven’t responded to standard therapy and as a first-line strategy. Results could inform future treatment options for pediatric UC.
Pediatric patients with active or refractory ulcerative colitis, parents/caregivers, pediatric gastroenterologists, and researchers interested in microbiome-based therapies and nutritional interventions.
What To Know
What To Know This is a registered interventional clinical trial (recruiting) studying fecal microbiota transplantation (FMT) combined with partial enteral nutrition (PEN) in children with ulcerative colitis.
The study has two groups: treating refractory pediatric UC who have failed standard therapies, and testing FMT+PEN as a first-line option for active pediatric UC. Participants receive PEN (Peptamen) and at least one course of FMT, with repeat FMTs allowed at roughly 2-month intervals.
Clinical response and remission measured by PUCAI at 8–12 weeks after FMT are listed as primary outcomes. The trial is planned at Tongji Hospital in Wuhan, China, with planned enrollment of 30.
What this means for patients This trial is testing whether adding FMT to a high-percentage enteral nutrition plan can induce clinical response or remission in children with active or treatment-refractory UC. It does not report results—this is a trial record describing design, eligibility, interventions, and outcomes.
If you are considering participation, the registry lists key inclusion/exclusion criteria and procedures (including colonoscopy and FMT delivery methods). Practical note Because this is a trial registration, there are no efficacy or safety results here.
Methods of FMT delivery and timing, and definitions of refractory disease and remission (PUCAI thresholds), are specified in the record; discuss eligibility and risks with the study team or your clinician if interested.
This is a clinicaltrials.gov recruitment record describing the study design and planned outcomes; it does not contain trial results. The study is small (planned n=30) and conducted at a single center. FMT delivery methods and safety considerations are covered in the protocol; eligibility excludes children with contraindications to FMT administration methods.
