Measuring EDN (a protein from eosinophils) in people with eosinophilic esophagitis
Official title: Noninvasive Biomarkers Correlated With Esophageal Eosinophilic Infiltrate in Pediatric Patients With Eosinophilic Esophagitis
Run by Assistance Publique - Hôpitaux de Paris · NCT06387030 · Data updated 2026-11-12
This will see if measuring EDN in blood, urine, saliva, stool, and esophageal samples can show active disease or remission in people with suspected or known eosinophilic esophagitis who are having an upper GI endoscopy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 2 Years to 17 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | April 19, 2024 |
| Main results expected | April 2026 |
| Study ends | April 2026 |
| Registry record updated | September 2, 2025 |
| Trial ID | NCT06387030 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People with symptoms suggesting eosinophilic esophagitis or with previously proven eosinophilic esophagitis who are scheduled for diagnostic or follow‑up upper GI endoscopy are ideal candidates.
✕Probably not a fit
Patients with other chronic esophageal conditions such as inflammatory bowel disease, esophageal atresia, or achalasia are excluded and are unlikely to benefit from the results of this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Patients with suspected or previously diagnosed eosinophilic esophagitis who are scheduled for upper GI endoscopy will be recruited at a single center. Investigators will collect blood, urine, unstimulated saliva, stool, and esophageal biopsies (during endoscopy) to measure EDN levels and related markers. EDN concentrations from non‑invasive samples will be compared with esophageal histology (eosinophil counts) and clinical findings to determine how well they reflect disease activity. The protocol aims to identify whether non‑invasive EDN measurements could reduce the need for repeat endoscopies to monitor the condition.
Why it matters
Potential benefit: If successful, this could provide a non‑invasive biomarker to help monitor disease activity and reduce the number of repeat endoscopies.
How similar studies have gone: Previous work measuring EDN in serum, esophageal brushings, and biopsies has shown promising associations with disease activity, but urinary EDN has not yet been studied in eosinophilic esophagitis.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Suspicion of eosinophilic esophagitis due to symptoms of esophageal dysfunction OR follow-up of eosinophilic esophagitis histologically proven at a previous upper GI endoscopy. * Indication for upper GI endoscopy for diagnosis or follow-up of eosinophilic esophagitis, or for pathology other than eosinophilic esophagitis. Exclusion Criteria: \- Patients with chronic inflammatory bowel disease, esophageal atresia or achalasia
Where it's running
-
Nutrition et gastro-entérologie pédiatrique-Trousseau Hospital
Paris, France Recruiting
Study contacts
- Principal investigator: Anaïs LEMOINE, Doctor — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Anaïs LEMOINE, Doctor
- Email: anais.lemoine@aphp.fr
- Phone: 00 33 1 44 73 60 69
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.