Effect of heated foods on remission in children with Eosinophilic Esophagitis
Pediatric Eosinophilic Esophagitis (pedEoE): Effect of Allergen Heat Denaturation on EoE Remission: a Pilot Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 12 Months to 18 Years |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT06381219 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are younger than 12 months or have active EoE will not benefit from this study.
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 performed: While this approach is novel, similar studies exploring dietary interventions in EoE have shown promise, suggesting potential for success.
Eligibility criteria
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 this trial is running
Leuven, Vlaams-Brabant
- 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
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.