Pathogenic Study of Adult Immune Enteropathies

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04280510
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Institut National de la Santé Et de la Recherche Médicale, France
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Georgia MALAMUT, MD, PhD
Principal Investigator Affiliation	APHP, Université de Paris (Université Paris Descartes)
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Celiac Disease, Autoimmune Enteropathy, Inflammatory Bowel Diseases

Arms & Interventions

Arms

: Active coeliac patients

Patients with active coeliac disease

: Treated coeliac patients

Patients with coeliac disease on gluten free diet

: Sprue type I

Patients with refractory coeliac disease of type I

: Sprue type II

Patients with refractory coeliac disease of type II

: Intestinal Lymphoproliferations

Patients with intestinal lymphoproliferations

: Non coeliac enteropathies

Patients with non coeliac immune-mediated enteropathy

: Patients without neoplastic or inflammatory intestinal disease

Patients without neoplastic or inflammatory intestinal disease

Interventions

Genetic: - Blood sample collection; gastrointestinal biopsy

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

Contact a Trial Team

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