Investigating immune-related intestinal diseases in adults
Pathogenic Study of Adult Immune Enteropathies
Institut National de la Santé Et de la Recherche Médicale, France · NCT04280510
This study looks at how certain immune-related gut diseases in adults affect the balance of cells in the intestines and liver to see if it can lead to serious complications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France (other gov) |
| Locations | 4 sites (Créteil and 3 other locations) |
| Trial ID | NCT04280510 on ClinicalTrials.gov |
What this trial studies
This observational study examines the mechanisms that disrupt intestinal homeostasis in conditions such as celiac disease, autoimmune enteropathy, and inflammatory bowel diseases. It aims to understand how lymphocyte transformations can lead to lymphomatous complications associated with these immune enteropathies. Additionally, the study will assess the loss of hepatic lymphocytic homeostasis in liver-related autoimmune diseases through blood sample collection and gastrointestinal biopsies.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and over who are diagnosed with celiac disease, autoimmune enteropathy, or inflammatory bowel diseases.
Not a fit: Patients who are pregnant or unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of immune enteropathies, potentially reducing complications for patients.
How similar studies have performed: While this study focuses on specific mechanisms in immune enteropathies, similar studies have shown promise in understanding autoimmune diseases, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Créteil and 3 other locations
- Hôpital Henri Mondor — Créteil, France (NOT_YET_RECRUITING)
- Hôpital Bicêtre — Le Kremlin-Bicêtre, France (NOT_YET_RECRUITING)
- Hôpital Saint Louis — Paris, France (NOT_YET_RECRUITING)
- Hôpital Cochin — Paris, France (RECRUITING)
Study contacts
- Principal investigator: Georgia MALAMUT, MD, PhD — APHP, Université de Paris (Université Paris Descartes)
- Study coordinator: Georgia MALAMUT, MD, PhD
- Email: georgia.malamut@aphp.fr
- Phone: 33 1 58 41 41 76
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Celiac Disease, Autoimmune Enteropathy, Inflammatory Bowel Diseases, Autoimmune enteropathy, Primary immunodeficiency, Intestinal lymphoma, Liver autoimmune diseases