Innate Immunity in Eosinophilic Esophagitis

NCT03640975 | Completed

• 1 other identifier: NI17020JHLJ
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Eosinophilic Esophagitis

Keywords

eosinophilic esophagitis; children; innate immunity

Outcome Measures

Primary Outcomes (1)

• The numbers of innate immune cells

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

  1 year

Secondary Outcomes (2)

• Microbiota

  1 year

• Metabolomics

  1 year

Study Arms (2)

case : eosinophilic esophagitis

Children with symptoms suggestive of EoE and requiring an upper gastrointestinal endoscopy with biopsies of the esophageal mucosa

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

Other: Endoscopy

Interventions

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.

case : eosinophilic esophagitis; control

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children presenting with symptoms suggestive of EoE and requiring an upper gastrointestinal endoscopy with biopsies of the esophageal mucosa

You may qualify if:

• 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

You may not qualify if:

• immune deficiency
• auto immune diseases

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Necker-Enfants Malades Hospital

Paris, 75015, France

Location

Related Publications (1)

• 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.

  PMID: 37006253 RESULT

MeSH Terms

Conditions

Eosinophilic Esophagitis

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Guillaume LEZMI, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: August 21, 2018
• Study Start: July 11, 2018
• Primary Completion: October 28, 2019
• Study Completion: October 28, 2019
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)