Clinical Trial: MICROPRUNG : Intestinal Microbiota Analysis in Patients With or Without Hirschsprung's Associated EnteroColitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: MICROPRUNG : Intestinal Microbiota Analysis in Patients With or Without Hirschsprung's Associated EnteroColitis

Brief Summary:

Hirschsprung disease is a congenital abnormality due to the lack of migration of neural crest cells in myenteric and submucosal plexi of the bowel wall. The consequence is the absence of parasympathetic control of the distal bowel from the anal sphincter to various levels. The most common type of Hirschsprung disease alters the rectosigmoid (80%). The incidence is around 1/5000 live births. This anomaly requires a surgical ablation of the aganglionic segment.

Regardless of the surgical complications, patients with Hirschsprung disease are exposed to the risk of Hirschsprung Associated EnteroColitis (HAEC). This variable risk, 4-54%, is responsible to a major part of Hirschsprung disease morbimortality. Its onset is more frequent during the first two years of life and then decrease with age.

Its pathogenesis remains unclear but could be due to intestinal homeostasis breakdown that involves microbiota, intestinal barrier, immune system and enteric nervous system. This breakdown of the mutual benefit relation due to microbiota or bowel anomaly is known to be responsible of Crohn's disease onset. Some studies emphasize the role of microbiota in the pathogenesis of HAEC, but the techniques or the methodology with small numbers of patients limit any conclusion or clinical use.

We hypothesize microbiota is a major factor in HAEC onset and in their functional bowel problems. Considering HAEC is more frequent the first two years, we think intestinal microbiota changes with time in those patients. This project is innovative because we will use high throughput sequencing methods and analysis for microbiome analysis on fecal samples from a multicenter cohort of patients at various ages.

Multicentre transversal study.

Primary objective :

Characterize intestinal microbiota in patients with or without HAEC.

Secondary objectives :

  • Look for a difference in microbiota composition between patients with or without HAEC ;
  • Study the evolution with age of the microbiota in Hirschsprung disease patients ;
  • Study predominant taxonomic classification elements in both groups.

Sponsor: Rennes University Hospital

Current Primary Outcome: Intestinal microbiota composition [ Time Frame: Sampling day ]

Characterize intestinal microbiota in patients with or without HAEC


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Rennes University Hospital

Dates:
Date Received: August 2, 2016
Date Started: June 2016
Date Completion: December 2017
Last Updated: August 2, 2016
Last Verified: August 2016