Characterization of Phenotype and Genotype of Early Onset Enteropathies

Inflammatory Bowel Disease Clinical Trial

— IMMUNOBIOTA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02614911
• Other study ID #: IMIS2014-01
• Status: Recruiting
• Start date: June 16, 2014
• Est. completion date: June 15, 2054

Study information

• Verified date: December 2023
• Source: Imagine Institute
• Contact: Nadine Cerf-Bensussan
• Phone: + 33 1 42 75 42 88
• Email: nadine.cerf-bensussan[@]inserm.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1445
• Est. completion date: June 15, 2054
• Est. primary completion date: June 15, 2054
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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,

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Pellegrin-Enfants	Bordeaux
France	Hôpital pédiatrique de Lyon	Bron
France	Hôpital Jeanne de Flandre, CHRU de Lille	Lille
France	Hôpital d'enfants de la Timone	Marseille
France	Hôpital Robert Debré	Paris
France	Hôpital Saint Antoine	Paris
France	Hôpital Trousseau	Paris
France	Necker - Enfants Malades Hospital	Paris
France	Hôpital Sud	Rennes
France	CHU Hautepierre	Strasbourg
France	Hôpital des Enfants	Toulouse
France	Hôpital Clocheville, CHU de Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Imagine Institute

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increasing the current rate (20%) of genetic characterization of early onset entheropathies	Currently, around 20% of early onset entheropathies are genetically characterized. Investigators want to increase this rate via this research protocol.; Our long term objective is to characterize phenotypes and genotypes of patients with early onset enteropathies.	40 years