Characterizing genetic and phenotypic traits of early onset enteropathies
Host-Microbiota Interactions Across the Gut Immune System: Characterization of Phenotype and Genotype of Early Onset Enteropathies
This study is trying to understand the genetic and physical traits of young children with early onset gut issues to see how their bodies handle gut health despite having many microbes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1445 (estimated) |
| Sex | All |
| Sponsor | Imagine Institute Academic / other |
| Locations | 12 sites (Bordeaux and 11 other locations) |
| Trial ID | NCT02614911 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on understanding the phenotypes and genotypes of patients with early onset enteropathies, particularly those who develop symptoms within the first six years of life. Investigators will collect biological samples, primarily blood, from affected patients and their healthy relatives to analyze genetic factors. The goal is to identify human pathways that help maintain intestinal health despite the presence of numerous microbes in the gut. This research aims to provide insights into the underlying mechanisms of inflammatory bowel disease in young patients.
Who should consider this trial
Good fit: Ideal candidates include patients with severe chronic enteropathy who show symptoms early in life, particularly within the first two years.
Not a fit: Patients who have participated in any therapeutic clinical study within the last 30 days may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of early onset enteropathies, potentially guiding future treatments.
How similar studies have performed: While this study is focused on a specific population, similar genetic characterization studies have shown promise in understanding complex conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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,
Where this trial is running
Bordeaux and 11 other locations
- Centre Hospitalier Pellegrin-Enfants — Bordeaux, France (Recruiting)
- Hôpital pédiatrique de Lyon — Bron, France (Recruiting)
- Hôpital Jeanne de Flandre, CHRU de Lille — Lille, France (Recruiting)
- Hôpital d'enfants de la Timone — Marseille, France (Recruiting)
- Hôpital Saint Antoine — Paris, France (Recruiting)
- Necker - Enfants Malades Hospital — Paris, France (Recruiting)
- Hôpital Robert Debré — Paris, France (Recruiting)
- Hôpital Trousseau — Paris, France (Recruiting)
- Hôpital Sud — Rennes, France (Recruiting)
- CHU Hautepierre — Strasbourg, France (Not_yet_recruiting)
- Hôpital des Enfants — Toulouse, France (Recruiting)
- Hôpital Clocheville, CHU de Tours — Tours, France (Recruiting)
Study contacts
- Principal investigator: Frank Ruemmele — Necker - Enfants Malades Hospital
- Study coordinator: Nadine Cerf-Bensussan
- Email: nadine.cerf-bensussan@inserm.fr
- Phone: + 33 1 42 75 42 88
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.