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Recruiting NCT02614911

Characterization of Phenotype and Genotype of Early Onset Enteropathies

Observational Inflammatory Bowel Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biological sampling.
Who it may be relevant to
Registry conditions: Inflammatory Bowel Disease. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Host-Microbiota Interactions Across the Gut Immune System: Characterization of Phenotype and Genotype of Early Onset Enteropathies

Overview

This study has been set up in order to characterize phenotypes and genotypes of patients with early onset enteropathies. In that goal, Investigators will collect biological samples (mainly blood) of patients suffering from early onset enteropathies and their healthy relatives.

Detailed description

This study specifically aims at the genetic analysis of early onset enteropathies with the goal in mind to delineate human pathways necessary to maintain intestinal homeostasis despite the considerable density of microbes colonizing the distal part of the human intestine.

Interventions

  • Other Biological sampling
    Biological sampling including blood, feces, biopsies...

Primary outcome measures

  • Increasing the current rate (20%) of genetic characterization of early onset entheropathies [Time frame: 40 years]

Eligibility criteria

Main Inclusion Criteria:

  • Severe chronic enteropathy
  • Patients developing their first symptoms within the first 6 years of life and, in priority within the first two years of life, or patients with a disease of later onset, in case of a familial history suggestive of inherited mutations notably in families comprising several affected members
  • OR : Be a patient's relative, even if presenting with enteropathy of later onset.

Main Exclusion Criteria:

  • Subject having participated to any therapeutical clinical study in the 30 days preceding the inclusion in this study,

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

France · 12 centers
  • Centre Hospitalier Pellegrin-Enfants — Bordeaux
  • Hôpital pédiatrique de Lyon — Bron
  • Hôpital Jeanne de Flandre, CHRU de Lille — Lille
  • Hôpital d'enfants de la Timone — Marseille
  • Hôpital Saint Antoine — Paris
  • Necker - Enfants Malades Hospital — Paris
  • Hôpital Robert Debré — Paris
  • Hôpital Trousseau — Paris
  • … and 4 more centers

Identifiers

NCT: NCT02614911 · IMIS2014-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗