Inflammatory Bowel DiseaseIMMUNOBIOTANCT02614911
Characterization of Phenotype and Genotype of Early Onset Enteropathies
An observational study of Inflammatory Bowel Disease, run by Imagine Institute at 12 sites in France.
Trial summary
This study has been set up in order to characterize phenotypes and genotypes of patients with early onset enteropathies. In that goal, Investigators will collect biological samples (mainly blood) of patients suffering from early onset enteropathies and their healthy relatives. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- Biological sampling
- How many people
- 1,445 participants
- Where
- 12 sitesFrance
- Study dates
- 16 Jun 2014to 15 Jun 2054
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Inclusion of patients with chronic severe entheropathy and of their healthy relatives
Main Inclusion Criteria:
- Severe chronic enteropathy
- Patients developing their first symptoms within the first 6 years of life and, in priority within the first two years of life, or patients with a disease of later onset, in case of a familial history suggestive of inherited mutations notably in families comprising several affected members
- OR : Be a patient's relative, even if presenting with enteropathy of later onset.
Main Exclusion Criteria:
- Subject having participated to any therapeutical clinical study in the 30 days preceding the inclusion in this study,
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
France12 sites, 12 recruiting
- Recruiting
Centre Hospitalier Pellegrin-Enfants
Bordeaux, 33076
Thierry Lamireau, thierry.lamireau@chu-bordeaux.fr
- Recruiting
Hôpital pédiatrique de Lyon
Bron, 69677
Alain Lachaux, +33 4 72 12 94 32, alain.lachaux@chu-lyon.fr
- Recruiting
Hôpital Jeanne de Flandre, CHRU de Lille
Lille, 59037
Frédéric Gottrant, +33 3 20 44 46 95, frederic.gottrant@chru-lille.fr
- Recruiting
Hôpital d'enfants de la Timone
Marseille, 13385
Alexandre Fabre, +33 4 91 38 80 60, alexandre.fabre@ap.hm.fr
- Recruiting
Hôpital Saint Antoine
Paris, 75012
Philippe Seksik, +33 1 49 28 31 62, philippe.seksik@nck.aphp.fr
- Recruiting
Necker - Enfants Malades Hospital
Paris, 75015
Frank Ruemmele, +33 1 42 75 42 88, frank.ruemmele@aphp.fr
- Recruiting
Hôpital Robert Debré
Paris, 75019
Jean-Pierre Hugot, +33 1 40 03 57 12, jean-pierre.hugot@rdb.aphp.fr
- Recruiting
Hôpital Trousseau
Paris, 75020
Patrick Tounian, +33 1 44 73 64 46, p.tounian@trs.aphp.fr
- Recruiting
Hôpital Sud
Rennes, 35203
Alain Dabadie, +33 2 99 26 67 33, alain.dabadie@chu-rennes.fr
- Not yet recruiting
CHU Hautepierre
Strasbourg, 67000
Julie Rebeuh, julie.rebeuh@chru-strasbourg.fr
- Recruiting
Hôpital des Enfants
Toulouse, 31059
Anne Breton, +33 5 34 55 85 60, breton.a@chu-toulouse.fr
- Recruiting
Hôpital Clocheville, CHU de Tours
Tours, 37000
Stéphanie Willot, +33 2 47 47 47 55, stephanie.willot@univ-tours.fr
About this study
Official title: Host-Microbiota Interactions Across the Gut Immune System: Characterization of Phenotype and Genotype of Early Onset Enteropathies
This study has been set up in order to characterize phenotypes and genotypes of patients with early onset enteropathies.
In that goal, Investigators will collect biological samples (mainly blood) of patients suffering from early onset enteropathies and their healthy relatives.
Read the detailed description
This study specifically aims at the genetic analysis of early onset enteropathies with the goal in mind to delineate human pathways necessary to maintain intestinal homeostasis despite the considerable density of microbes colonizing the distal part of the human intestine.
- Conditions
- Inflammatory Bowel Disease
- Being tested
- Biological sampling
- Keywords
- Early Onset Entheropathy
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological samplingOther
Biological sampling including blood, feces, biopsies...
| Study group | Role | What they receive |
|---|---|---|
| Sick patients | Biological sampling of blood for all patients. Biological sampling of saliva, biopsies (skin and endoscopic), feces, for some patients Receives: Other: Biological sampling | |
| Healthy relatives | Biological sampling of blood for all healthy relatives Receives: Other: Biological sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increasing the current rate (20%) of genetic characterization of early onset entheropathies
Currently, around 20% of early onset entheropathies are genetically characterized. Investigators want to increase this rate via this research protocol.
Our long term objective is to characterize phenotypes and genotypes of patients with early onset enteropathies.
Measured: 40 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study start16 Jun 2014
- Primary completion15 Jun 2054 (estimated)
- Study completion15 Jun 2054 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- 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
- 1,445 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imagine Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank Ruemmele, Principal investigator, Necker - Enfants Malades Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614911
- Sponsor's protocol ID
- IMIS2014-01
- Acronym
- IMMUNOBIOTA
- Status last verified
- Apr 2025
- First submitted
- 10 Nov 2015
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Host-Microbiota Interactions Across the Gut Immune System: Characterization of Phenotype and Genotype of Early Onset Enteropathies
- ClinicalTrials.gov ID
- NCT02614911
- Acronym / sponsor ID
- IMMUNOBIOTA / IMIS2014-01
- Conditions
- Inflammatory Bowel Disease
- Keywords
- Early Onset Entheropathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,445 participants (estimated)
- Lead sponsor
- Imagine InstituteUniversity, hospital or other
- Study start
- 16 Jun 2014 (actual)
- Primary completion
- 15 Jun 2054 (estimated)
- Study completion
- 15 Jun 2054 (estimated)
- First posted
- 25 Nov 2015 (estimated)
- 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.
This study has been set up in order to characterize phenotypes and genotypes of patients with early onset enteropathies.
In that goal, Investigators will collect biological samples (mainly blood) of patients suffering from early onset enteropathies and their healthy relatives.
Detailed description
This study specifically aims at the genetic analysis of early onset enteropathies with the goal in mind to delineate human pathways necessary to maintain intestinal homeostasis despite the considerable density of microbes colonizing the distal part of the human intestine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sick patients | – | Other: Biological samplingBiological sampling of blood for all patients. Biological sampling of saliva, biopsies (skin and endoscopic), feces, for some patients |
| Healthy relatives | – | Other: Biological samplingBiological sampling of blood for all healthy relatives |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Inclusion of patients with chronic severe entheropathy and of their healthy relatives
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 |
|---|---|---|
| Biological samplingBiological sampling including blood, feces, biopsies... | Other | Healthy relatives, Sick patients |
Primary outcome
Increasing the current rate (20%) of genetic characterization of early onset entheropathies
Time frame: 40 years
Currently, around 20% of early onset entheropathies are genetically characterized. Investigators want to increase this rate via this research protocol. Our long term objective is to characterize phenotypes and genotypes of patients with early onset enteropathies.
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 30 Apr 2025.
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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.
Frank Ruemmele principal investigator
Necker - Enfants Malades Hospital
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease, run by Imagine Institute at 12 sites in France.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 Nadine Cerf-Bensussan (+ 33 1 42 75 42 88, nadine.cerf-bensussan@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increasing the current rate (20%) of genetic characterization of early onset entheropathies (time frame: 40 years). 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 30 Apr 2025.