Pathogenic Study of Adult Immune Enteropathies
Observational · No treatment assigned · 4 sites · Institut National de la Santé Et de la Recherche Médicale, France
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Celiac Disease, Autoimmune Enteropathy and Inflammatory Bowel Diseases. 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
- Ages 18 and older
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- 18 years or over
- affiliated to social insurance
- signed informed consent
There are also 3 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 200 participants are expected to take part.
- Start date: 2020-02-27.
- Main results expected around 2030-02-27 (estimate from the record).
- 4 study sites listed (1 marked recruiting) in France.
Main thing being measured
- Intestinal Lymphocytes count (Baseline)
In the researchers’ words
The study focuses the mechanisms underlying the loss of intestinal homeostasis in celiac disease, refractory celiac disease and other immune diseases such as monogenic enteropathy, inflammatory bowel diseases or drug induced intestinal diseases. Mechanisms of transformation of lymphocytes leading to onset of lymphomatous complications of immune enteropathies will be investigated.
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 | Celiac Disease; Autoimmune Enteropathy; Inflammatory Bowel Diseases |
| Lead sponsor | Institut National de la Santé Et de la Recherche Médicale, France |
| Collaborators | Imagine Institute |
| Enrollment | 200 (estimated) |
| Start date | 2020-02-27 |
| Primary completion (est.) | 2030-02-27 |
| First posted | 2020-02-21 |
| Last updated | 2025-09-18 |
| Official title | Pathogenic Study of Adult Immune Enteropathies |
| ClinicalTrials.gov ID | NCT04280510 |
Interventions
- Blood sample collection; gastrointestinal biopsy (Genetic)
Targeted Next generation sequencing and whole exome sequencing Phenotyping of intestinal lymphocytes, single cell analyses, cytokines dosage...
Full eligibility criteria (from the record)
Inclusion Criteria: * 18 years or over * affiliated to social insurance * signed informed consent Exclusion Criteria: * pregnancy * under guardianship * not able to sign informed consent
Locations (4)
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Henri Mondor | Créteil | France | Not yet recruiting |
| Hôpital Bicêtre | Le Kremlin-Bicêtre | France | Not yet recruiting |
| Hôpital Saint Louis | Paris | France | Not yet recruiting |
| Hôpital Cochin | Paris | 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.