Eosinophilic EsophagitisCLOENCT03640975
Innate Immunity in Eosinophilic Esophagitis
An observational study of Eosinophilic Esophagitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The main aim of this study is to assess the expression of innate lymphoid cells in the esophageal mucosa of children with eosinophilic esophagitis (EoE) and in control subjects Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- Endoscopy
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jul 2018to 28 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children presenting with symptoms suggestive of EoE and requiring an upper gastrointestinal endoscopy with biopsies of the esophageal mucosa
Who may be able to join
- children 1-18 years
- presenting with symptoms suggestive of EoE
- requiring an upper gastrointestinal endoscopy with biopsies of the esophageal mucosa in order to confirm or exclude the diagnosis
- Children paired for age in whom an endoscopy performed to explore symptoms of EoE revealed another condition (peptic oesophagitis, achalasia), or children paired for age in whom an endoscopy with biopsies has been performed to explore chronic abdominal or epigastric pain or suspected chronic inflammatory bowel disease, will be include as control subjects
Who cannot join
- immune deficiency
- auto immune diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Innate Lymphoid Cells in Eosinophilic Esophagitis (French Title : Cellules Lymphoïdes innées Dans l'Oesophagite à Eosinophiles)
The main aim of this study is to assess the expression of innate lymphoid cells in the esophageal mucosa of children with eosinophilic esophagitis (EoE) and in control subjects
Read the detailed description
Children (aged 1 to 18 years) presenting with symptoms suggestive of EoE and requiring an upper gastrointestinal endoscopy with biopsies of the esophageal mucosa in order to confirm or exclude the diagnosis of EoE will be included.
Children paired for age in whom an endoscopy performed to explore symptoms of EoE revealed another condition (peptic oesophagitis, achalasia), or children paired for age in whom an endoscopy with biopsies has been performed to explore chronic abdominal or epigastric pain or suspected chronic inflammatory bowel disease, will be include as control subjects.
The endoscopy will be performed under general anaesthesia using a flexible endoscope with an external diameter of between 4.9 and 9.2 mm, depending on the size of the child. In line with the guidelines, eight biopsies will be collected from the proximal, median and distal oesophagus for the routine analysis of esophageal remodelling and inflammation. Three of these biopsies will be used in the context of this study to analyse innate immune cells using flow cytometry and to determine the profile of cytokine expression. Two biopsies will be placed in sterile, 0.5 ml Nunc tubes containing a storage buffer (MACS® Tissue Storage Solution) and then stored in ice until the extraction of cells for cytometric analysis. The third specimen will be placed in a sterile tube and frozen immediately in liquid nitrogen for analyses of the esophageal microbiome.
ILC1, 2 and 3 and their sub-types will be identified by means of structural criteria (size and granularity) and differential membrane and intracellular labelling using the specific markers shown below. All acquisitions and analyses will be achieved using a 13-colour NovoCyte cytometer (AACEA) and its associated software (NovoAxpressTM), which are available in the laboratory.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- Endoscopy
- Keywords
- eosinophilic esophagitis, children, innate immunity
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoscopyOther
The endoscopy will be performed under general anaesthesia using a flexible endoscope with an external diameter of between 4.9 and 9.2 mm, depending on the size of the child. In line with the guidelines, eight biopsies will be collected from the proximal, median and distal oesophagus for the routine analysis of esophageal remodelling and inflammation. Three of these biopsies will be used in the context of this study to analyse innate immune cells using flow cytometry and to determine the profile of cytokine expression. Two biopsies will be placed in sterile, 0.5 ml Nunc tubes containing a storage buffer (MACS® Tissue Storage Solution) and then stored in ice until the extraction of cells for cytometric analysis . The third specimen will be placed in a sterile tube and frozen immediately in liquid nitrogen for analyses of the esophageal microbiome.
| Study group | Role | What they receive |
|---|---|---|
| case : eosinophilic esophagitis | Children with symptoms suggestive of EoE and requiring an upper gastrointestinal endoscopy with biopsies of the esophageal mucosa Receives: Other: Endoscopy | |
| control | Children in whom an endoscopy performed to explore symptoms of EoE revealed another condition (peptic oesophagitis, achalasia), or children in whom an endoscopy with biopsies has been performed to explore chronic abdominal or epigastric pain or suspected chronic inflammatory bowel disease Receives: Other: Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The numbers of innate immune cells
The counts of innate immune cells will be compared between EoE patients and controls
Measured: 1 year
Secondary outcomes (2)
Microbiota
Analyses of the composition of the esophageal microbiome will be performed using 16S rDNA sequencing after the extraction of DNA according to published protocols and/or using commercial kits (QlAamp DNA stool Mini Kit; QIAGEN). The pyrosequencing of 16S DNA, the identification of groups and phyla and initial biostatistical analyses will be carried out by specialised platforms.
Measured: 1 year
Metabolomics
Metabolomic analyses will be performed on plasma and red blood cell extracts using a device such as an Orbitrap-Exactive equipped with an electrospray source. The data will be analysed using data processing tools available in the laboratory (software systems for signal detection and automatic alignment, annotation and statistical analysis)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start11 Jul 2018
- Primary completion28 Oct 2019
- Study completion28 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Guillaume LEZMI, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640975
- Sponsor's protocol ID
- NI17020JHLJ
- Acronym
- CLOE
- Status last verified
- Mar 2026
- First submitted
- 17 Aug 2018
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adel-Patient K, Campeotto F, Grauso M, Guillon B, Moroldo M, Venot E, Dietrich C, Machavoine F, Castelli FA, Fenaille F, Molina TJ, Barbet P, Delacourt C, Leite-de-Moraes M, Lezmi G. Assessment of local and systemic signature of eosinophilic esophagitis (EoE) in children through multi-omics approaches. Front Immunol. 2023 Mar 15;14:1108895. doi: 10.3389/fimmu.2023.1108895. eCollection 2023.
PubMed 37006253
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innate Lymphoid Cells in Eosinophilic Esophagitis (French Title : Cellules Lymphoïdes innées Dans l'Oesophagite à Eosinophiles)
- ClinicalTrials.gov ID
- NCT03640975
- Acronym / sponsor ID
- CLOE / NI17020JHLJ
- Conditions
- Eosinophilic Esophagitis
- Keywords
- eosinophilic esophagitis, children, innate immunity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 11 Jul 2018 (actual)
- Primary completion
- 28 Oct 2019 (actual)
- Study completion
- 28 Oct 2019 (actual)
- First posted
- 21 Aug 2018 (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 main aim of this study is to assess the expression of innate lymphoid cells in the esophageal mucosa of children with eosinophilic esophagitis (EoE) and in control subjects
Detailed description
Children (aged 1 to 18 years) presenting with symptoms suggestive of EoE and requiring an upper gastrointestinal endoscopy with biopsies of the esophageal mucosa in order to confirm or exclude the diagnosis of EoE will be included.
Children paired for age in whom an endoscopy performed to explore symptoms of EoE revealed another condition (peptic oesophagitis, achalasia), or children paired for age in whom an endoscopy with biopsies has been performed to explore chronic abdominal or epigastric pain or suspected chronic inflammatory bowel disease, will be include as control subjects.
The endoscopy will be performed under general anaesthesia using a flexible endoscope with an external diameter of between 4.9 and 9.2 mm, depending on the size of the child. In line with the guidelines, eight biopsies will be collected from the proximal, median and distal oesophagus for the routine analysis of esophageal remodelling and inflammation. Three of these biopsies will be used in the context of this study to analyse innate immune cells using flow cytometry and to determine the profile of cytokine expression. Two biopsies will be placed in sterile, 0.5 ml Nunc tubes containing a storage buffer (MACS® Tissue Storage Solution) and then stored in ice until the extraction of cells for cytometric analysis. The third specimen will be placed in a sterile tube and frozen immediately in liquid nitrogen for analyses of the esophageal microbiome.
ILC1, 2 and 3 and their sub-types will be identified by means of structural criteria (size and granularity) and differential membrane and intracellular labelling using the specific markers shown below. All acquisitions and analyses will be achieved using a 13-colour NovoCyte cytometer (AACEA) and its associated software (NovoAxpressTM), which are available in the laboratory.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case : eosinophilic esophagitis | – | Other: EndoscopyChildren with symptoms suggestive of EoE and requiring an upper gastrointestinal endoscopy with biopsies of the esophageal mucosa |
| control | – | Other: EndoscopyChildren in whom an endoscopy performed to explore symptoms of EoE revealed another condition (peptic oesophagitis, achalasia), or children in whom an endoscopy with biopsies has been performed to explore chronic abdominal or epigastric pain or suspected chronic inflammatory bowel disease |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children presenting with symptoms suggestive of EoE and requiring an upper gastrointestinal endoscopy with biopsies of the esophageal mucosa
Key inclusion criteria (4 listed)
- children 1-18 years
- presenting with symptoms suggestive of EoE
- requiring an upper gastrointestinal endoscopy with biopsies of the esophageal mucosa in order to confirm or exclude the diagnosis
- Children paired for age in whom an endoscopy performed to explore symptoms of EoE revealed another condition (peptic oesophagitis, achalasia), or children paired for age in whom an endoscopy with biopsies has been performed to explore chronic abdominal or epigastric pain or suspected chronic inflammatory bowel disease, will be include as control subjects
Key exclusion criteria (2 listed)
- immune deficiency
- auto immune diseases
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 |
|---|---|---|
| EndoscopyThe endoscopy will be performed under general anaesthesia using a flexible endoscope with an external diameter of between 4.9 and 9.2 mm, depending on the size of the child. In line with the guidelines, eight biopsies will be collected from the proximal, median and distal oesophagus for the routine analysis of esophageal remodelling and inflammation. Three of these biopsies will be used in the context of this study to analyse innate immune cells using flow cytometry and to determine the profile of cytokine expression. Two biopsies will be placed in sterile, 0.5 ml Nunc tubes containing a storage buffer (MACS® Tissue Storage Solution) and then stored in ice until the extraction of cells for cytometric analysis . The third specimen will be placed in a sterile tube and frozen immediately in liquid nitrogen for analyses of the esophageal microbiome. | Other | case : eosinophilic esophagitis, control |
Primary outcome
The numbers of innate immune cells
Time frame: 1 year
The counts of innate immune cells will be compared between EoE patients and controls
2 secondary outcomes
Microbiota
Time frame: 1 year
Metabolomics
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Results publication: PubMed 37006253Adel-Patient K, Campeotto F, Grauso M, Guillon B, Moroldo M, Venot E, Dietrich C, Machavoine F, Castelli FA, Fenaille F, Molina TJ, Barbet P, Delacourt C, Leite-de-Moraes M, Lezmi G. Assessment of local and systemic signature of eosinophilic esophagitis (EoE) in children through multi-omics approaches. Front Immunol. 2023 Mar 15;14:1108895. doi: 10.3389/fimmu.2023.1108895. eCollection 2023.
- 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. This study is not recruiting at the moment.
Guillaume LEZMI, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eosinophilic Esophagitis, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The numbers of innate immune cells (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03640975, which also lists 1 linked publication.
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 5 Mar 2026; AzTrials last refreshed its copy on 29 Oct 2026.