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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Implementation of cow's milk in decreasingly heated forms

    Other intervention

    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 intervention

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

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Cow's milk allergen heat denaturationOther 1 intervention
Group B: Hen's egg allergen heat denaturationOther 1 intervention

Trial outcomes

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).

Time frame
40 weeks

Secondary outcomes

1

Maintained remission only in step 1 of the diet

The number of pedEoE children in whom remission remain with introduction of cake and/or 20' cooked cow's milk (step 1), but no longer with less heated proteins.

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

Association of remission with circulating IgG4 levels

To study whether remission (\>15 eosinophils per high-power field) is associated with specific circulating and/or local food protein IgG4 reduction (and increase upon unsuccessful introduction of less heated proteins). We will compare the IgG4 levels (expressed in g/L) in patients in remission and those not in remission.

Time frame
Bloods will be taken during every gastroscopy
3

Association of remission with IgG4 levels on biopsy

To study whether remission (\>15 eosinophils per high-power field) can be associated with changes in local IgG4 production that will be measured by biopsy staining and expressed in number of IgG4 positive plasma cells per high-power field. We will compare the local IgG4 production in patients in remission and those not in remission.

Time frame
At every gastroscopy
4

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

After PBMC isolation from the blood of pediatric patients, the PBMCs will be in vitro stimulated with food proteins. Then, B cell activation will be measured with flow cytometry by looking at the proportion of activated B cells compared to the total number of B cells.

Time frame
Up to 6 months

Other outcomes

Sponsors and contacts

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