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Characterization of Phenotype and Genotype of Early Onset Enteropathies (IMMUNOBIOTA)

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ClinicalTrials.gov Identifier: NCT02614911
Recruitment Status : Recruiting
First Posted : November 25, 2015
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Imagine Institute

Brief 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.


Condition or disease Intervention/treatment
Inflammatory Bowel Disease Other: Biological sampling

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.

Study Type : Observational
Estimated Enrollment : 346 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Host-Microbiota Interactions Across the Gut Immune System: Characterization of Phenotype and Genotype of Early Onset Enteropathies
Study Start Date : June 2014
Estimated Primary Completion Date : June 2029
Estimated Study Completion Date : June 2029

Group/Cohort Intervention/treatment
Sick patients
Biological sampling of blood for all patients. Biological sampling of saliva, biopsies (skin and endoscopic), feces, for some patients
Other: Biological sampling
Biological sampling including blood, feces, biopsies...

Healthy relatives
Biological sampling of blood for all healthy relatives
Other: Biological sampling
Biological sampling including blood, feces, biopsies...




Primary Outcome Measures :
  1. Increasing the current rate (20%) of genetic characterization of early onset entheropathies [ Time Frame: 15 years ]

    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.



Biospecimen Retention:   Samples With DNA

Collection of:

  • blood samples
  • feces
  • biopsies (intestine / skin)
  • saliva
  • urina


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Inclusion of patients with chronic severe entheropathy and of their healthy relatives
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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02614911


Contacts
Contact: Nadine Cerf-Bensussan + 33 1 42 75 42 88 nadine.cerf-bensussan@inserm.fr
Contact: Fabienne Charbit-Henrion +33 1 42 75 42 45 fabienne.charbit-henrion@inserm.fr

Locations
France
Centre Hospitalier Pellegrin-Enfants Recruiting
Bordeaux, France, 33076
Contact: Thierry Lamireau       thierry.lamireau@chu-bordeaux.fr   
Hôpital pédiatrique de Lyon Recruiting
Bron, France, 69677
Contact: Alain Lachaux    +33 4 72 12 94 32    alain.lachaux@chu-lyon.fr   
Hôpital Jeanne de Flandre, CHRU de Lille Recruiting
Lille, France, 59037
Contact: Frédéric Gottrant    +33 3 20 44 46 95    frederic.gottrant@chru-lille.fr   
Hôpital d'enfants de la Timone Recruiting
Marseille, France, 13385
Contact: Alexandre Fabre    +33 4 91 38 80 60    alexandre.fabre@ap.hm.fr   
Hôpital Saint Antoine Recruiting
Paris, France, 75012
Contact: Philippe Seksik    +33 1 49 28 31 62    philippe.seksik@nck.aphp.fr   
Necker - Enfants Malades Hospital Recruiting
Paris, France, 75015
Contact: Frank Ruemmele    +33 1 42 75 42 88    frank.ruemmele@aphp.fr   
Hôpital Robert Debré Recruiting
Paris, France, 75019
Contact: Jean-Pierre Hugot    +33 1 40 03 57 12    jean-pierre.hugot@rdb.aphp.fr   
Hôpital Trousseau Recruiting
Paris, France, 75020
Contact: Patrick Tounian    +33 1 44 73 64 46    p.tounian@trs.aphp.fr   
Hôpital Sud Recruiting
Rennes, France, 35203
Contact: Alain Dabadie    +33 2 99 26 67 33    alain.dabadie@chu-rennes.fr   
CHU Hautepierre Not yet recruiting
Strasbourg, France, 67000
Contact: Julie Rebeuh       julie.rebeuh@chru-strasbourg.fr   
Hôpital des Enfants Recruiting
Toulouse, France, 31059
Contact: Anne Breton    +33 5 34 55 85 60    breton.a@chu-toulouse.fr   
Hôpital Clocheville, CHU de Tours Recruiting
Tours, France, 37000
Contact: Stéphanie Willot    +33 2 47 47 47 55    stephanie.willot@univ-tours.fr   
Sponsors and Collaborators
Imagine Institute
Investigators
Principal Investigator: Frank Ruemmele Necker - Enfants Malades Hospital

Responsible Party: Imagine Institute
ClinicalTrials.gov Identifier: NCT02614911     History of Changes
Other Study ID Numbers: IMIS2014-01
First Posted: November 25, 2015    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: August 2017

Keywords provided by Imagine Institute:
Early Onset Entheropathy

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Intestinal Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases