Effect of heated foods on remission in children with Eosinophilic Esophagitis
Official title: Pediatric Eosinophilic Esophagitis (pedEoE): Effect of Allergen Heat Denaturation on EoE Remission: a Pilot Trial
Run by Universitaire Ziekenhuizen KU Leuven · NCT06381219 · Data updated 2026-11-12
This study is testing if giving heated versions of hen's egg and cow's milk can help children with Eosinophilic Esophagitis stay in remission and possibly build tolerance to these foods.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 12 Months to 18 Years |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Status | Recruiting |
| Started | December 19, 2023 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | May 5, 2026 |
| Trial ID | NCT06381219 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 12 months and older with a diagnosis of EoE induced by cow's milk or hen's egg who are currently in remission.
✕Probably not a fit
Patients who are younger than 12 months or have active EoE will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot trial investigates whether introducing heated food products, specifically hen's egg and cow's milk, can help maintain remission in children with Eosinophilic Esophagitis (EoE). The study involves a controlled food challenge where children will consume heated versions of these allergens, followed by gradual reintroduction of less heated forms. Participants will undergo regular gastroscopies to assess eosinophil levels in biopsies, which will indicate remission status. The goal is to determine if this approach can lead to tolerance induction in affected children.
Why it matters
Potential benefit: If successful, this study could provide a new dietary management strategy for children with EoE, potentially improving their quality of life.
How similar studies have gone: While this approach is novel, similar studies exploring dietary interventions in EoE have shown promise, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: All children (aged 12 months and older) presenting (since 1-1-2014: moment of diagnostic guideline standardization for pedEoE) with diagnosed pedEoE at UZ Leuven eliminating either hen's egg or cow's milk or both and in complete remission after their latest biopsy (no longer than 12 months earlier, but preferentially as short as possible after their latest biopsy) are eligible for the study. If the last biopsy has been performed more than 12 months earlier, a new gastro-duodenoscopy will be performed to verify remission and rule out e.g. active gastritis. If they are on PPI and/or local budesonide treatment, this should be stable for at least 3 months and will remain untouched during the entire study. We will include 18 pedEoE subjects suffering from cow's milk induced EoE and 18 suffering from hen's egg induced EoE. Exclusion Criteria: * Children younger than 12 months * Children with active pedEoE * Children who refuse to adhere to the protocol * Children with associated IgE mediated hen's egg and/or cow's milk allergy with specific IgE antibody titers that predict active (baked egg and/or baked milk) food allergy with cut-off titers as used at the consultation of allergy (KLL). Those children will become eligible however if their titers decrease while the study is still open.
Where it's running
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UZ Leuven Gasthuisberg
Leuven, Vlaams-Brabant, Belgium Recruiting
Study contacts
- Principal investigator: Ilse Hoffman, Prof. Dr. — Co-investigator, pediatric gastro-enterology
- Study coordinator: Dominique Bullens, Prof. Dr.
- Email: dominique.bullens@kuleuven.be
- Phone: 0032016343801
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Upadacitinib for Eosinophilic Esophagitis in adults not responding to standard therapy
This study tests whether upadacitinib, taken with topical corticosteroids, can reduce disease activity in adults with eosinophilic esophagitis who still have symptoms.
-
A registry for adults with esophageal movement and reflux problems.
This project will collect esophageal function tests (manometry, pH-impedance, FLIP) and clinical data from adults with reflux or swallowing symptoms to see if combining these results helps guide diagnosis and long-term care.
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Using a mucosal impedance device to help diagnose chronic esophageal problems
This test tries a mucosal impedance device during upper endoscopy to see if it helps diagnose people with chronic reflux (GERD) or eosinophilic esophagitis.
-
Esophageal string test to screen for eosinophilic esophagitis in adults of African descent with swallowing problems
This study will test whether a 1-hour esophageal string test can detect eosinophilic esophagitis in adults born in Africa (or with African parents) who have trouble swallowing.
-
Improving management of eosinophilic esophagitis in children and adolescents
This study is trying to find better ways to manage eosinophilic esophagitis in kids and teens by using simple tests to avoid invasive procedures and improve their quality of life.
-
How common FIRE is and what it looks like in children with eosinophilic esophagitis
This project will see how often and in what ways Food Induced Immediate Response of the Esophagus (FIRE) occurs in children aged 6–17 who have eosinophilic esophagitis.
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.