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Recruiting NCT04280510

Pathogenic Study of Adult Immune Enteropathies

Observational Celiac Disease Autoimmune Enteropathy Inflammatory Bowel Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood sample collection; gastrointestinal biopsy.
Who it may be relevant to
Registry conditions: Celiac Disease, Autoimmune Enteropathy, Inflammatory Bowel Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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. Mechanisms of loss of hepatic lymphocytic homeostasis will also be assessed in liver associated diseases.

Interventions

  • Genetic Blood sample collection; gastrointestinal biopsy
    Targeted Next generation sequencing and whole exome sequencing Phenotyping of intestinal lymphocytes, single cell analyses, cytokines dosage...

Primary outcome measures

  • Intestinal Lymphocytes count [Time frame: Baseline]
  • DNA sequencing [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • 18 years or over
  • affiliated to social insurance
  • signed informed consent

Exclusion criteria

  • pregnancy
  • under guardianship
  • not able to sign informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

France · 4 centers
  • Hôpital Henri Mondor — Créteil
  • Hôpital Bicêtre — Le Kremlin-Bicêtre
  • Hôpital Saint Louis — Paris
  • Hôpital Cochin — Paris

Identifiers

NCT: NCT04280510 · C19-07 · 2019-A01594-53

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗