Pathogenic Study of Adult Immune Enteropathies (ENTEROPAH)

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases; Celiac Disease; Autoimmune Enteropathy
• Intervention / Treatment: Genetic: Blood sample collection; gastrointestinal biopsy

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Georgia MALAMUT, MD, PhD; Phone Number: 33 1 58 41 41 76; Email: georgia.malamut@aphp.fr
• Study Contact Backup: Name: Nadine CERF-BENSUSSAN, MD, PhD; Phone Number: 33 1 42 75 42 88; Email: nadine.cerf-bensussan@inserm.fr

Study Locations

• France
  • Clichy, France, 92110
    • Not yet recruiting
    • Hopital Beaujon
    • Contact: Yoram Bouhnik, MD, PhD; Email: yoram.bouhnik@aphp.fr
    • Principal Investigator: Yoram Bouhnik, MD, PhD
    • Sub-Investigator: Xavier Treton, MD, PhD
  • Créteil, France, 94010
    • Not yet recruiting
    • Hopital Henri Mondor
    • Contact: Iradj Sobhani, MD, PhD; Email: iradj.sobhani@aphp.fr
    • Principal Investigator: Iradj Sobhani, MD, PhD
    • Sub-Investigator: Aurélien Amiot, MD, PhD
  • Le Kremlin Bicêtre, France, 94270
    • Not yet recruiting
    • Hôpital Bicêtre
    • Contact: Franck Carbonnel, MD, PhD; Email: franck.carbonnel@aphp.fr
    • Principal Investigator: Franck Carbonnel, MD, PhD
  • Paris, France, 75012
    • Not yet recruiting
    • Hôpital Saint Antoine
    • Principal Investigator: Laurent Beaugerie, MD, PhD
    • Contact: Laurent Beaugerie, MD, PhD
  • Paris, France, 75014
    • Recruiting
    • Hopital Cochin
    • Contact: Georgia Malamut, MD, PhD; Email: georgia.malamut@aphp.fr
    • Principal Investigator: Georgia MALAMUT, MD, PhD
    • Principal Investigator: Stanislas CHAUSSADE, MD, PhD
    • Sub-Investigator: Vered ABITBOL, MD, PhD
  • Paris, France, 75010
    • Not yet recruiting
    • Hôpital Saint Louis
    • Principal Investigator: Matthieu Allez, MD, PhD
    • Contact: Matthieu ALLEZ, MD, PhD; Email: matthieu.allez@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients planned to have blood specimens and possible upper and/or lower digestive endoscopy.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Active coeliac patients; Patients with active coeliac disease	Genetic: Blood sample collection; gastrointestinal biopsy; Targeted Next generation sequencing and whole exome sequencing Phenotyping of intestinal lymphocytes, single cell analyses, cytokines dosage...
Treated coeliac patients; Patients with coeliac disease on gluten free diet	Genetic: Blood sample collection; gastrointestinal biopsy; Targeted Next generation sequencing and whole exome sequencing Phenotyping of intestinal lymphocytes, single cell analyses, cytokines dosage...
Sprue type I; Patients with refractory coeliac disease of type I	Genetic: Blood sample collection; gastrointestinal biopsy; Targeted Next generation sequencing and whole exome sequencing Phenotyping of intestinal lymphocytes, single cell analyses, cytokines dosage...
Sprue type II; Patients with refractory coeliac disease of type II	Genetic: Blood sample collection; gastrointestinal biopsy; Targeted Next generation sequencing and whole exome sequencing Phenotyping of intestinal lymphocytes, single cell analyses, cytokines dosage...
Intestinal Lymphoproliferations; Patients with intestinal lymphoproliferations	Genetic: Blood sample collection; gastrointestinal biopsy; Targeted Next generation sequencing and whole exome sequencing Phenotyping of intestinal lymphocytes, single cell analyses, cytokines dosage...
Non coeliac enteropathies; Patients with non coeliac immune-mediated enteropathy	Genetic: Blood sample collection; gastrointestinal biopsy; Targeted Next generation sequencing and whole exome sequencing Phenotyping of intestinal lymphocytes, single cell analyses, cytokines dosage...
Patients without neoplastic or inflammatory intestinal disease	Genetic: Blood sample collection; gastrointestinal biopsy; Targeted Next generation sequencing and whole exome sequencing Phenotyping of intestinal lymphocytes, single cell analyses, cytokines dosage...

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intestinal Lymphocytes count	Lymphocytes isolation	Baseline
DNA sequencing	Targeted Next Generation sequencing	Baseline

Collaborators and Investigators

• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Collaborators: Imagine Institute
• Investigators: Principal Investigator: Georgia MALAMUT, MD, PhD, APHP, Université de Paris (Université Paris Descartes)

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2020
• Primary Completion (Anticipated): February 27, 2028
• Study Completion (Anticipated): February 27, 2028

Study Registration Dates

• First Submitted: January 20, 2020
• First Submitted That Met QC Criteria: February 20, 2020
• First Posted (Actual): February 21, 2020

Study Record Updates

• Last Update Posted (Actual): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 28, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Primary immunodeficiency; Celiac Disease; Autoimmune enteropathy; Intestinal lymphoma; Liver autoimmune diseases
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Gastroenteritis; Malabsorption Syndromes; Inflammatory Bowel Diseases; Celiac Disease; Intestinal Diseases
• Other Study ID Numbers: C19-07; 2019-A01594-53 (Registry Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No