Pediatric Eosinophilic Esophagitis (pedEoE): Effect of Allergen Heat Denaturation on EoE Remission: a Pilot Trial

NCT06381219 | Recruiting

• 1 other identifier: s67001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to study whether the introduction of heated food products (more specifically heated hen's egg and/or cow's milk) in children with EoE would be possible without re-occurrence of the eosinophilic inflammation, while the intake of less heated products might cause disease recidive. Moreover, we would like to study whether the gradual re-introduction of less heated products after the most heated form is tolerated, could lead to tolerance induction in EoE.

Conditions

Eosinophilic Esophagitis

Outcome Measures

Primary Outcomes (1)

• Maintained remission of EoE

  Primary end-point of the study is to study the number of pedEoE children by inclusion on hen's egg and/or cow's milk free diet with potential remaining remission (\<15 eosinophils/hpf on esophageal biopsies) after 8 weeks (re)introduction of heat-denatured hen's egg and/or cow's milk proteins (introduced sequentially as on the one hand baked egg (cake), hard-boiled egg, omelet and soft-boiled egg and on the other hand 20' cooked cow's milk, 15', 10' and 5' cooked cow's milk).

  40 weeks

Secondary Outcomes (7)

• Maintained remission only in step 1 of the diet

  Assessment of failed remission 8 weeks after step 2 but successful remission after step 1

• Association of remission with circulating IgG4 levels

  Bloods will be taken during every gastroscopy

• Association of remission with IgG4 levels on biopsy

  At every gastroscopy

• In vitro B cell test to mimic B cell activation after stimulation

  Up to 6 months

• Correlation between QoL and remission

  Up to 45 weeks

Study Arms (2)

Cow's milk allergen heat denaturation

OTHER

Children with an EoE in remission AND a previous diet excluding any form of cow's milk will undergo an oral food challenge with extensively heated cow's milk (20'). Afterwards they will be instructed to ensure regular intake of 20' heated cow's milk. After 8 weeks of (re)introduction they will be assessed for potential remaining remission (\<15 eosinophils/hpf on esophagal biopsies). If remission is sustained, they will sequentially decrease the degree of heat denaturation by decreasing the cooking time: 15', 10' and 5' cooked cow's milk. At the end, parents will have the choice to add a final step of raw cow's milk. After every 8 weeks of every new step, a gastroscopy will be performed to assess maintained remission. If remission is lost, they will go back to a strict avoidance diet for at least 10 weeks.

Other: Implementation of cow's milk in decreasingly heated forms

Hen's egg allergen heat denaturation

OTHER

Children with an EoE in remission AND a previous diet excluding any form of hen's egg will undergo an oral food challenge with strongly heated hen's egg (in cake). Afterwards they will be instructed to ensure regular intake of cake. After 8 weeks of (re)introduction they will be assessed for potential remaining remission (\<15 eosinophils/hpf on esophagal biopsies). If remission is sustained, they will sequentially decrease the degree of heat denaturation as follows: hard-boiled egg, omelet and soft-boiled egg. At the end, parents will have the choice to add a final step of raw egg. After every 8 weeks of every new step, a gastroscopy will be performed to assess maintained remission. If remission is lost, they will go back to a strict avoidance diet for at least 10 weeks.

Other: Implementation of hen's egg in decreasingly heated forms

Interventions

Implementation of cow's milk in decreasingly heated forms OTHER

Implementation of cow's milk in decreasingly heated forms to assess maintained remission of EoE

Cow's milk allergen heat denaturation

Implementation of hen's egg in decreasingly heated forms OTHER

Implementation of hen's egg in decreasingly heated forms to assess maintained remission of EoE

Hen's egg allergen heat denaturation

Eligibility Criteria

• Age: 12 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven Gasthuisberg

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Ilse Hoffman, Prof. Dr.

  Co-investigator, pediatric gastro-enterology

  PRINCIPAL INVESTIGATOR

• Gert De Hertogh, Prof. Dr.

  Co-investigator, pathological anatomy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique Bullens, Prof. Dr.

CONTACT

0032016343801; dominique.bullens@kuleuven.be

Marleen Jannis

CONTACT

0032016343801; marleen.jannis@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinic Head in Pediatrics-Allergy at UZ Leuven, Head of the Allergy and Clinical Immunology Research group at KU Leuven (prof., dr.)

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: April 24, 2024
• Study Start: December 19, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-05

Locations

BE (1)