CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 23 enrolled
Drug / intervention
Fecal Microbiota Transplantation (FMT)biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02108821
NCT02108821Phase 1Completed

A Study of Fecal Microbiota Transplantation in Pediatric Patients With Relapsed Inflammatory Bowel Disease.

Children's Mercy Hospital Kansas City·interventional·Posted Apr 9, 2014·Updated Feb 4, 2021

In Brief

A Phase 1 clinical trial evaluating Fecal Microbiota Transplantation (FMT) for Inflammatory Bowel Diseases (IBD) and 2 related conditions. Completed, enrolled 23 participants across 1 site.

Detailed Summary

A disturbance in the diversity of gut bacterial composition could be linked to several immune mediated diseases including inflammatory bowel diseases (IBD). IBD can be classified into Crohn's Disease (CD) and Ulcerative Colitis (UC). Both these diseases occur from abnormal immune reaction to resident gut bacteria.The process of fecal microbiota transplantation (FMT) where fecal bacteria from a healthy individual is transferred into a recipient, has recently received attention as an alternative therapy for individuals affected with these life-altering diseases. In this study, the investigators will perform fecal transplantation on the subjects meeting inclusion criteria, to determine the efficacy and safety of this therapy in subjects with IBD (CD and UC) who are not responding to first line therapy, and are in a flare.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 9, 2014
Enrollment StartMar 1, 2014
Primary CompletionSep 30, 2016
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 12.2 years ago

Interventions

Fecal Microbiota Transplantation (FMT)biological

The process of fecal microbiota transplantation (FMT), where fecal bacteria from a healthy individual is transferred into a recipient as an alternative therapy for individuals affected with these life-altering diseases: Crohn's Disease (CD), and/or Ulcerative Colitis (UC).