Measuring EDN (a protein from eosinophils) in people with eosinophilic esophagitis
Noninvasive Biomarkers Correlated With Esophageal Eosinophilic Infiltrate in Pediatric Patients With Eosinophilic Esophagitis
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 2 Years to 17 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT06387030 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Paris
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.