drugset / Trial / NCT01947101

Fecal Microbiota Transplantation (FMT) for Treatment of Ulcerative Colitis in Children

NCT01947101

Phase 1 Completed 6 enrolled Baylor College of Medicine
NaSingle-groupOpen-labelTreatment

Summary

Patients diagnosed with ulcerative colitis (UC), a specific type of inflammatory bowel disease, will be invited to take part in this study. The investigators do not know what causes UC. However, the microbes (such as bacteria and viruses), which normally live in our intestines are thought to play an important role in the development of UC. There are many treatment options for UC such as steroids,and other medications that decrease inflammation. However, none of these can cure the disease. This study aims to treat pediatric UC in an alternative fashion by changing the microbes in the gut by giving the participant's stool specimens from healthy adult individuals. There is some evidence from a few cases of adult UC that this therapy may cure the disease or at least provide long lasting suppression (remission) of the symptoms. The investigators would like to test this therapeutic intervention in children with UC. The purpose of this study is to (1) examine the microbiome of stool and colon (2) and to determine whether healthy-donated stool enemas can treat pediatric ulcerative colitis. (3) The investigators will also study the effects of the treatment on colonic gene expression.

Timeline

Start
2014-02
Primary completion
2014-12
Completion
2016-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Fecal Microbiota Transplant Other / unclassified Rectal

Indications