Celiac DiseaseENTEROPATHNCT04280510
Pathogenic Study of Adult Immune Enteropathies
An observational study of Celiac Disease and Autoimmune Enteropathy, run by Institut National de la Santé Et de la Recherche Médicale, France at 4 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease, Autoimmune Enteropathy, Inflammatory Bowel Diseases
- What is being tested?
- Blood sample collection; gastrointestinal biopsy
- How many people
- 200 participants
- Where
- 4 sitesFrance
- Study dates
- 27 Feb 2020to 27 Feb 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients planned to have blood specimens and possible upper and/or lower digestive endoscopy.
Who may be able to join
- 18 years or over
- affiliated to social insurance
- signed informed consent
Who cannot join
- pregnancy
- under guardianship
- not able to sign informed consent
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Not yet recruiting
Hôpital Henri Mondor
Créteil, 94010
Iradj Sobhani, MD, PhD, iradj.sobhani@aphp.fr
Iradj Sobhani, MD, PhD
- Not yet recruiting
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
Franck Carbonnel, MD, PhD, franck.carbonnel@aphp.fr
Franck Carbonnel, MD, PhD
- Not yet recruiting
Hôpital Saint Louis
Paris, 75010
Matthieu ALLEZ, MD, PhD, matthieu.allez@aphp.fr
Matthieu Allez, MD, PhD
- Recruiting
Hôpital Cochin
Paris, 75014
Georgia Malamut, MD, PhD, georgia.malamut@aphp.fr
Georgia MALAMUT, MD, PhD
About this study
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.
- Being tested
- Blood sample collection; gastrointestinal biopsy
- Keywords
- Celiac Disease, Autoimmune enteropathy, Primary immunodeficiency, Intestinal lymphoma, Liver autoimmune diseases
- Medical subject headings
- Celiac Disease, Autoimmune enteropathy, Inflammatory Bowel Diseases, Primary Immunodeficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collection; gastrointestinal biopsyGenetic
Targeted Next generation sequencing and whole exome sequencing Phenotyping of intestinal lymphocytes, single cell analyses, cytokines dosage...
| Study group | Role | What they receive |
|---|---|---|
| Active coeliac patients | Patients with active coeliac disease Receives: Genetic: Blood sample collection; gastrointestinal biopsy | |
| Treated coeliac patients | Patients with coeliac disease on gluten free diet Receives: Genetic: Blood sample collection; gastrointestinal biopsy | |
| Sprue type I | Patients with refractory coeliac disease of type I Receives: Genetic: Blood sample collection; gastrointestinal biopsy | |
| Sprue type II | Patients with refractory coeliac disease of type II Receives: Genetic: Blood sample collection; gastrointestinal biopsy | |
| Intestinal Lymphoproliferations | Patients with intestinal lymphoproliferations Receives: Genetic: Blood sample collection; gastrointestinal biopsy | |
| Non coeliac enteropathies | Patients with non coeliac immune-mediated enteropathy Receives: Genetic: Blood sample collection; gastrointestinal biopsy | |
| Patients without neoplastic or inflammatory intestinal disease | Patients without neoplastic or inflammatory intestinal disease Receives: Genetic: Blood sample collection; gastrointestinal biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal Lymphocytes count
Lymphocytes isolation
Measured: Baseline
DNA sequencing
Targeted Next Generation sequencing
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start27 Feb 2020
- Primary completion27 Feb 2030 (estimated)
- Study completion27 Feb 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Imagine Institute
- Responsible party
- Sponsor
- Investigators
- Georgia MALAMUT, MD, PhD, Principal investigator, APHP, Université de Paris (Université Paris Descartes)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280510
- Sponsor's protocol ID
- C19-07
- Other IDs
- 2019-A01594-53
- Acronym
- ENTEROPATH
- Status last verified
- Oct 2026
- First submitted
- 20 Jan 2020
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathogenic Study of Adult Immune Enteropathies
- ClinicalTrials.gov ID
- NCT04280510
- Acronym / sponsor ID
- ENTEROPATH / C19-07
- Keywords
- Celiac Disease, Autoimmune enteropathy, Primary immunodeficiency, Intestinal lymphoma, Liver autoimmune diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- Imagine Institute
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- 27 Feb 2030 (estimated)
- Study completion
- 27 Feb 2033 (estimated)
- First posted
- 21 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Active coeliac patients | – | Genetic: Blood sample collection; gastrointestinal biopsyPatients with active coeliac disease |
| Treated coeliac patients | – | Genetic: Blood sample collection; gastrointestinal biopsyPatients with coeliac disease on gluten free diet |
| Sprue type I | – | Genetic: Blood sample collection; gastrointestinal biopsyPatients with refractory coeliac disease of type I |
| Sprue type II | – | Genetic: Blood sample collection; gastrointestinal biopsyPatients with refractory coeliac disease of type II |
| Intestinal Lymphoproliferations | – | Genetic: Blood sample collection; gastrointestinal biopsyPatients with intestinal lymphoproliferations |
| Non coeliac enteropathies | – | Genetic: Blood sample collection; gastrointestinal biopsyPatients with non coeliac immune-mediated enteropathy |
| Patients without neoplastic or inflammatory intestinal disease | – | Genetic: Blood sample collection; gastrointestinal biopsyPatients without neoplastic or inflammatory intestinal disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients planned to have blood specimens and possible upper and/or lower digestive endoscopy.
Key inclusion criteria (3 listed)
- 18 years or over
- affiliated to social insurance
- signed informed consent
Key exclusion criteria (3 listed)
- pregnancy
- under guardianship
- not able to sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample collection; gastrointestinal biopsyTargeted Next generation sequencing and whole exome sequencing Phenotyping of intestinal lymphocytes, single cell analyses, cytokines dosage... | Genetic | Active coeliac patients, Intestinal Lymphoproliferations, Non coeliac enteropathies, Patients without neoplastic or inflammatory intestinal disease, Sprue type I, Sprue type II, Treated coeliac patients |
Primary outcome
Intestinal Lymphocytes count
Time frame: Baseline
Lymphocytes isolation
DNA sequencing
Time frame: Baseline
Targeted Next Generation sequencing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Georgia MALAMUT, MD, PhD principal investigator
APHP, Université de Paris (Université Paris Descartes)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease and Autoimmune Enteropathy, run by Institut National de la Santé Et de la Recherche Médicale, France at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Georgia MALAMUT, MD, PhD (33 1 58 41 41 76, georgia.malamut@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intestinal Lymphocytes count (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.