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

NCT02857205 | Completed

• 2 other identifiers: 35RC15_9873_MICROPRUNG2015-A01317-42
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 7

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. The study hypothesizes microbiota is a major factor in HAEC onset and in their functional bowel problems. Considering HAEC is more frequent the first two years, it's thought that intestinal microbiota changes with time in those patients. This project is innovative because it 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. This study has the potential to significantly modify clinical practice for Hirschsprung disease patients: a better care for HAEC and functional troubles thanks to a better understanding of their microbiota, targetted antibiotic treatment for HAEC, prophylactic treatment of patients at high risk of HAEC.

Conditions

Hirschsprung Disease

Keywords

Hirschsprung Associated EnteroColitis (HAEC)

Outcome Measures

Primary Outcomes (1)

• Intestinal microbiota composition

  Characterize intestinal microbiota in patients with or without HAEC

  Sampling day

Study Arms (1)

Fecal samples

OTHER

High throughput sequencing methods and analysis for microbiome analysis on fecal samples from a multicenter cohort of patients at various ages.

Other: Fecal samples

Interventions

Fecal samples OTHER

High throughput sequencing methods and analysis for microbiome analysis on fecal samples from a multicenter cohort of patients at various ages.

Fecal samples

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients from 0 to 16 years ;
• With rectosigmoid Hirschsprung's disease confirmed by rectal biopsies and at surgery;
• Already operated on, whatever the surgical technique was ;
• With a health care insurance;
• Clear information and signed consent form

You may not qualify if:

• Long segment Hirschsprung disease ;
• Syndromic Hirschsprung disease ;
• Down syndrome.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (7)

Angers University Hospital

Angers, 49000, France

Location

Brest University Hospital

Brest, 29000, France

Location

Caen Univeristy Hospital

Caen, 14000, France

Location

Nantes University Hospital

Nantes, 44000, France

Location

Poitiers University Hospital

Poitiers, 86000, France

Location

Rennes University Hospital

Rennes, 35000, France

Location

Tours University Hospital

Tours, 37000, France

Location

Related Publications (1)

• Arnaud AP, Cousin I, Schmitt F, Petit T, Parmentier B, Levard G, Podevin G, Guinot A, DeNapoli S, Hervieux E, Flaum V, De Vries P, Randuineau G, David-Le Gall S, Buffet-Bataillon S, Boudry G. Different Fecal Microbiota in Hirschsprung's Patients With and Without Associated Enterocolitis. Front Microbiol. 2022 Jun 30;13:904758. doi: 10.3389/fmicb.2022.904758. eCollection 2022.

  PMID: 35847080 DERIVED

MeSH Terms

Conditions

Hirschsprung Disease

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Megacolon; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Alexis ARNAUD, MD

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: August 5, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: September 1, 2018
• Last Updated: September 13, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)