Characterization of Phenotype and Genotype of Early Onset Enteropathies
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 →
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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