Pathogenic Study of Adult Immune Enteropathies

Recruiting

• Conditions: Autoimmune Enteropathy; Celiac Disease; Inflammatory Bowel Diseases
• Interventions: Genetic: Blood sample collection; gastrointestinal biopsy

• Registration Number: NCT04280510
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-20
• Study First Submitted QC: 2020-02-20
• Study First Posted: 2020-02-21
• Study Start: 2020-02-27
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30
• Primary Completion: 2028-02-27
• Study Completion: 2028-02-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Active coeliac patients	Blood sample collection; gastrointestinal biopsy	Patients with active coeliac disease
Sprue type II	Blood sample collection; gastrointestinal biopsy	Patients with refractory coeliac disease of type II
Non coeliac enteropathies	Blood sample collection; gastrointestinal biopsy	Patients with non coeliac immune-mediated enteropathy
Treated coeliac patients	Blood sample collection; gastrointestinal biopsy	Patients with coeliac disease on gluten free diet
Patients without neoplastic or inflammatory intestinal disease	Blood sample collection; gastrointestinal biopsy	Patients without neoplastic or inflammatory intestinal disease
Sprue type I	Blood sample collection; gastrointestinal biopsy	Patients with refractory coeliac disease of type I
Intestinal Lymphoproliferations	Blood sample collection; gastrointestinal biopsy	Patients with intestinal lymphoproliferations

Primary Outcome Measures

Name	Time	Method
Intestinal Lymphocytes count	Baseline	Lymphocytes isolation
DNA sequencing	Baseline	Targeted Next Generation sequencing

Trial Locations

Locations (6)

Hôpital Beaujon; 🇫🇷 Clichy, France

Hôpital Henri Mondor; 🇫🇷 Créteil, France

Hôpital Bicêtre; 🇫🇷 Le Kremlin Bicêtre, France

Hôpital Saint Louis; 🇫🇷 Paris, France

Hôpital Cochin; 🇫🇷 Paris, France

Hôpital Saint Antoine; 🇫🇷 Paris, France