NCT03582969

Capsulized Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis Patients

High Intensity, Multi-Donor, Oral Capsulized Fecal Microbiota Transplantation in Newly Diagnosed Pediatric Patients With Mild to Moderate Ulcerative Colitis - a Double Blind, Placebo-Controlled Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Assaf-Harofeh Medical Center · Other Government
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

Fecal Microbiota Transplantation(FMT) - reconstitution of normal flora by a stool transplant from a healthy individual, is increasingly being recognized as a therapeutic modality for diseases that are associated with gut dysbiosis. This is a placebo-controlled, double blinded interventional study evaluating multiple, oral, fecal microbiota transplantation, administered in newly diagnosed pediatric patients with mild-moderate UC. The primary objective is to assess the safety and feasibility of multiple, oral, fecal microbiota transplantation, in newly diagnosed pediatric patients with mild-moderate UC. All processing will occur at the Center for Microbiome Research at Assaf Harofeh Medical Center, under GMP conditions.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
OTHER	Fecal transplantation	Fecal transplantation administered orally via frozen capsules.
OTHER	Placebo	Placebo capsules

Timeline

• Start date: 2018-08-01
• Primary completion: 2021-07-01
• Completion: 2022-07-01
• First posted: 2018-07-11
• Last updated: 2018-07-11

Locations

1 site across 1 country: Israel