Actively Recruiting

Phase Not Applicable
Age: 2Years - 17Years
All Genders
ID06387030

Noninvasive Biomarkers Correlated With Esophageal Eosinophilic Infiltrate in Pediatric Patients With Eosinophilic Esophagitis

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-09-02

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

A

Assistance Publique - Hôpitaux de Paris

Lead Sponsor

I

INRAe - Micalis Institute - Jouy en Josas

Collaborating Sponsor

AI-Summary

What this Trial Is About

Eosinophilic esophagitis is a chronic inflammatory digestive disease caused by eosinophil buildup in the esophagus, leading to problems with esophageal function. This condition mostly affects children and requires frequent invasive procedures like endoscopies with biopsies to diagnose and monitor treatment effectiveness. Researchers are exploring non-invasive biomarkers such as Eosinophil-Derived Neurotoxin (EDN) and the role of esophageal, salivary, and fecal microbiota to improve diagnosis and follow-up methods. The study involves pediatric patients undergoing upper gastrointestinal endoscopy either for suspected eosinophilic esophagitis or for monitoring known cases. During the procedure, researchers collect blood, urine, stool, saliva, esophageal brushings, and four additional esophageal biopsies. These samples will be analyzed to measure EDN levels and other biomarkers, including cytokine profiles and metabolomic data, alongside studying the microbiota composition to understand their relationship with the disease. Participants and their parents will complete questionnaires about quality of life and symptoms on the day of endoscopy. The research team will compare the biomarker levels with the eosinophil counts in biopsies to establish correlations. The goal is to develop less invasive ways to monitor disease activity, reducing the need for repeated endoscopies. The study will last four months, during which various clinical, biological, and microbiological outcomes will be assessed to better understand and manage eosinophilic esophagitis in children.

CONDITIONS

Brief Title

EDN and Eosinophilic Esophagitis

Who Can Participate

Age: 2Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Suspicion of eosinophilic esophagitis due to symptoms of esophageal dysfunction or follow-up of histologically proven eosinophilic esophagitis
  • Indication for upper GI endoscopy for diagnosis or follow-up of eosinophilic esophagitis or other pathology
  • Age between 2 and 17 years
Not Eligible

You will not qualify if you...

  • History of chronic inflammatory bowel disease
  • History of esophageal atresia
  • History of achalasia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for upper GI endoscopy

Diagnostic Evaluation

Duration - Day of endoscopy

Participants undergo upper gastrointestinal endoscopy with esophageal biopsies, esophageal brushing, and collection of blood, urine, stool, and saliva samples to evaluate disease activity and identify biomarkers.

1 visit (in-person) during hospitalization for digestive endoscopy

Long-term Monitoring

Duration - 4 months

Participants are followed over 4 months to monitor urinary, serum, and endoluminal EDN levels, cytokine profiles, microbiota composition, and clinical symptoms to assess disease activity and treatment response.

Follow-up assessments as per clinical care; visit schedule varies

Trial Site Locations

Total: 1 location

1

Nutrition et gastro-entérologie pédiatrique-Trousseau Hospital

Paris, France, 75012

Actively Recruiting

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Research Team

A

Anaïs LEMOINE, Doctor

P

Patrick TOUNIAN, Professor of University

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Frequently Asked Questions

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