Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis (UC)

Launched by BIAO ZOU · Dec 25, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for children with Ulcerative Colitis (UC), a condition that causes inflammation in the intestines. The researchers want to see if using fecal microbiota transplantation (FMT) along with partial enteral nutrition (PEN) can help children whose UC hasn't improved with standard treatments. They are also looking at how effective and safe this combination is for children who are newly diagnosed with mild-to-moderate UC.

To participate in the trial, children must be between the ages of 2 and 16 and have mild-to-moderate UC. They should not have any genetic diseases and must be willing to undergo regular colonoscopies, which are examinations of the colon. Some children may not be eligible if they've previously received certain treatments or if they have specific health conditions. Participants can expect to receive the new treatment and will be closely monitored for its effects on their condition. This study is currently recruiting participants, and it's an exciting opportunity for families seeking new options for managing UC in children.

Gender

ALL

Eligibility 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