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

April 29, 2025 updated by: Imagine Institute

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

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

1445

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bordeaux, France, 33076
      • Bron, France, 69677
        • Recruiting
        • Hôpital pédiatrique de Lyon
        • Contact:
      • Lille, France, 59037
      • Marseille, France, 13385
        • Recruiting
        • Hôpital d'Enfants de la Timone
        • Contact:
      • Paris, France, 75019
      • Paris, France, 75012
      • Paris, France, 75015
        • Recruiting
        • Necker - Enfants Malades Hospital
        • Contact:
      • Paris, France, 75020
        • Recruiting
        • Hôpital Trousseau
        • Contact:
      • Rennes, France, 35203
      • Strasbourg, France, 67000
      • Toulouse, France, 31059
      • Tours, France, 37000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Inclusion of patients with chronic severe entheropathy and of their healthy relatives

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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...

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

This is where you will find people and organizations involved with this study.

Sponsor

Imagine Institute

Investigators

  • Principal Investigator: Frank Ruemmele, Necker - Enfants Malades Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2014

Primary Completion (Estimated)

June 15, 2054

Study Completion (Estimated)

June 15, 2054

Study Registration Dates

First Submitted

November 10, 2015

First Submitted That Met QC Criteria

November 24, 2015

First Posted (Estimated)

November 25, 2015

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 29, 2025

Last Verified

April 1, 2025

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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