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Completed

NCT Number: NCT03640975

Innate Immunity in Eosinophilic Esophagitis

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • immune deficiency
  • auto immune diseases

Treatment and study plan

Endoscopy

Other

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.

Primary outcomes

  1. The numbers of innate immune cells

    Time frame: 1 year

    The counts of innate immune cells will be compared between EoE patients and controls

Secondary outcomes

  1. Microbiota

    Time frame: 1 year

    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.

  2. Metabolomics

    Time frame: 1 year

    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)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Innate Lymphoid Cells in Eosinophilic Esophagitis (French Title : Cellules Lymphoïdes innées Dans l'Oesophagite à Eosinophiles)

Acronym: CLOE

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 21, 2018
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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