- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02614911
Characterization of Phenotype and Genotype of Early Onset Enteropathies (IMMUNOBIOTA)
Host-Microbiota Interactions Across the Gut Immune System: Characterization of Phenotype and Genotype of Early Onset Enteropathies
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Nadine Cerf-Bensussan
- Phone Number: + 33 1 42 75 42 88
- Email: nadine.cerf-bensussan@inserm.fr
Study Contact Backup
- Name: Fabienne Charbit-Henrion
- Phone Number: +33 1 42 75 42 45
- Email: fabienne.charbit-henrion@inserm.fr
Study Locations
-
-
-
Bordeaux, France, 33076
- Recruiting
- Centre Hospitalier Pellegrin-Enfants
-
Contact:
- Thierry Lamireau
- Email: thierry.lamireau@chu-bordeaux.fr
-
Bron, France, 69677
- Recruiting
- Hôpital pédiatrique de Lyon
-
Contact:
- Alain Lachaux
- Phone Number: +33 4 72 12 94 32
- Email: alain.lachaux@chu-lyon.fr
-
Lille, France, 59037
- Recruiting
- Hôpital Jeanne de Flandre, CHRU de Lille
-
Contact:
- Frédéric Gottrant
- Phone Number: +33 3 20 44 46 95
- Email: frederic.gottrant@chru-lille.fr
-
Marseille, France, 13385
- Recruiting
- Hopital d'Enfants de la Timone
-
Contact:
- Alexandre Fabre
- Phone Number: +33 4 91 38 80 60
- Email: alexandre.fabre@ap.hm.fr
-
Paris, France, 75019
- Recruiting
- Hôpital Robert Debré
-
Contact:
- Jean-Pierre Hugot
- Phone Number: +33 1 40 03 57 12
- Email: jean-pierre.hugot@rdb.aphp.fr
-
Paris, France, 75012
- Recruiting
- Hopital Saint Antoine
-
Contact:
- Philippe Seksik
- Phone Number: +33 1 49 28 31 62
- Email: philippe.seksik@nck.aphp.fr
-
Paris, France, 75015
- Recruiting
- Necker - Enfants Malades Hospital
-
Contact:
- Frank Ruemmele
- Phone Number: +33 1 42 75 42 88
- Email: frank.ruemmele@aphp.fr
-
Paris, France, 75020
- Recruiting
- Hopital Trousseau
-
Contact:
- Patrick Tounian
- Phone Number: +33 1 44 73 64 46
- Email: p.tounian@trs.aphp.fr
-
Rennes, France, 35203
- Recruiting
- Hopital Sud
-
Contact:
- Alain Dabadie
- Phone Number: +33 2 99 26 67 33
- Email: alain.dabadie@chu-rennes.fr
-
Strasbourg, France, 67000
- Not yet recruiting
- CHU HautePierre
-
Contact:
- Julie Rebeuh
- Email: julie.rebeuh@chru-strasbourg.fr
-
Toulouse, France, 31059
- Recruiting
- Hôpital des Enfants
-
Contact:
- Anne Breton
- Phone Number: +33 5 34 55 85 60
- Email: breton.a@chu-toulouse.fr
-
Tours, France, 37000
- Recruiting
- Hôpital Clocheville, CHU de Tours
-
Contact:
- Stéphanie Willot
- Phone Number: +33 2 47 47 47 55
- Email: stephanie.willot@univ-tours.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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,
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
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
|
Biological sampling including blood, feces, biopsies...
|
Healthy relatives
Biological sampling of blood for all healthy relatives
|
Biological sampling including blood, feces, biopsies...
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Increasing the current rate (20%) of genetic characterization of early onset entheropathies
Time Frame: 40 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. |
40 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Frank Ruemmele, Necker - Enfants Malades Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IMIS2014-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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