IBD (general)Recruiting
Characterization of Phenotype and Genotype of Early Onset Enteropathies
Observational · No treatment assigned · 12 sites · Imagine Institute
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Inflammatory Bowel Disease. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Age range not stated in the record
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- 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…
Plus 3 more requirement(s). Only the trial team can confirm whether you qualify.
What's involved
- About 1445 participants are expected to take part.
- Start date: 2014-06-16.
- Main results expected around 2054-06-15 (estimate from the record).
- 12 study sites listed (11 marked recruiting) in France.
Main thing being measured
- Increasing the current rate (20%) of genetic characterization of early onset entheropathies (40 years)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Inflammatory Bowel Disease |
| Lead sponsor | Imagine Institute |
| Enrollment | 1445 (estimated) |
| Start date | 2014-06-16 |
| Primary completion (est.) | 2054-06-15 |
| First posted | 2015-11-25 |
| Last updated | 2025-04-30 |
| Official title | Host-Microbiota Interactions Across the Gut Immune System: Characterization of Phenotype and Genotype of Early Onset Enteropathies |
| ClinicalTrials.gov ID | NCT02614911 |
Interventions
- Biological sampling (Other)
Biological sampling including blood, feces, biopsies...
Full eligibility criteria (from the record)
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,
Locations (12)
| Site | City | Country | Site status |
|---|---|---|---|
| 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 |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.