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

Sponsor
Universitaire Ziekenhuizen KU Leuven
Study ID
NCT06381219
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
12 Months - 18 Years
Healthy Volunteers
Not accepted

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
  • 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

Study Details

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.

Key Dates

Start date
Dec 19, 2023
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Other: Cow's milk allergen heat denaturation
    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: Hen's egg allergen heat denaturation
    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.

Primary Outcome Measure

Maintained remission of EoE [ Time Frame: 40 weeks ]

Central Contacts

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