Pathogenic Study of Adult Immune Enteropathies

Inflammatory Bowel Diseases Clinical Trial

— ENTEROPAH  

Official title:

Pathogenic Study of Adult Immune Enteropathies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04280510
• Other study ID #: C19-07
• Secondary ID: 2019-A01594-53
• Status: Recruiting
• Start date: February 27, 2020
• Est. completion date: February 27, 2028

Study information

• Verified date: July 2020
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Georgia MALAMUT, MD, PhD
• Phone: 33 1 58 41 41 76
• Email: georgia.malamut[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 27, 2028
• Est. primary completion date: February 27, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or over

• affiliated to social insurance

• signed informed consent

Exclusion Criteria:

• pregnancy

• under guardianship

• not able to sign informed consent

Related Conditions & MeSH terms

• Autoimmune Enteropathy
• Celiac Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Beaujon	Clichy
France	Hôpital Henri Mondor	Créteil
France	Hôpital Bicêtre	Le Kremlin Bicêtre
France	Hôpital Cochin	Paris
France	Hôpital Saint Antoine	Paris
France	Hôpital Saint Louis	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France	Imagine Institute

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intestinal Lymphocytes count	Lymphocytes isolation	Baseline
Primary	DNA sequencing	Targeted Next Generation sequencing	Baseline