NCT04280510

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
83mo left

Started Feb 2020

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Feb 2020Feb 2033

First Submitted

Initial submission to the registry

January 20, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 21, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

February 27, 2020

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2030

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2033

Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

10 years

First QC Date

January 20, 2020

Last Update Submit

September 17, 2025

Conditions

Celiac DiseaseAutoimmune EnteropathyInflammatory Bowel Diseases

Keywords

Celiac DiseaseAutoimmune enteropathyPrimary immunodeficiencyIntestinal lymphomaLiver autoimmune diseases

Outcome Measures

Primary Outcomes (2)

  • Intestinal Lymphocytes count

    Lymphocytes isolation

    Baseline

  • DNA sequencing

    Targeted Next Generation sequencing

    Baseline

Study Arms (7)

Active coeliac patients

Patients with active coeliac disease

Genetic: Blood sample collection; gastrointestinal biopsy

Treated coeliac patients

Patients with coeliac disease on gluten free diet

Genetic: Blood sample collection; gastrointestinal biopsy

Sprue type I

Patients with refractory coeliac disease of type I

Genetic: Blood sample collection; gastrointestinal biopsy

Sprue type II

Patients with refractory coeliac disease of type II

Genetic: Blood sample collection; gastrointestinal biopsy

Intestinal Lymphoproliferations

Patients with intestinal lymphoproliferations

Genetic: Blood sample collection; gastrointestinal biopsy

Non coeliac enteropathies

Patients with non coeliac immune-mediated enteropathy

Genetic: Blood sample collection; gastrointestinal biopsy

Patients without neoplastic or inflammatory intestinal disease

Patients without neoplastic or inflammatory intestinal disease

Genetic: Blood sample collection; gastrointestinal biopsy

Interventions

Blood sample collection; gastrointestinal biopsyGENETIC

Targeted Next generation sequencing and whole exome sequencing Phenotyping of intestinal lymphocytes, single cell analyses, cytokines dosage...

Active coeliac patientsIntestinal LymphoproliferationsNon coeliac enteropathiesPatients without neoplastic or inflammatory intestinal diseaseSprue type ISprue type IITreated coeliac patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hôpital Henri Mondor

Créteil, 94010, France

NOT YET RECRUITING

Hôpital Bicêtre

Le Kremlin-Bicêtre, 94270, France

NOT YET RECRUITING

Hôpital Saint Louis

Paris, 75010, France

NOT YET RECRUITING

Hôpital Cochin

Paris, 75014, France

RECRUITING

MeSH Terms

Conditions

Celiac DiseaseAutoimmune enteropathyInflammatory Bowel DiseasesPrimary Immunodeficiency Diseases

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGastroenteritisGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Georgia MALAMUT, MD, PhD

    APHP, Université de Paris (Université Paris Descartes)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Georgia MALAMUT, MD, PhD

CONTACT

33 1 58 41 41 76georgia.malamut@aphp.fr

Anaïs LEVESCOT, MD, PhD

CONTACT

33 1 42 75 42 77anais.levescot@inserm.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2020

First Posted

February 21, 2020

Study Start

February 27, 2020

Primary Completion (Estimated)

February 27, 2030

Study Completion (Estimated)

February 27, 2033

Last Updated

September 18, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)