Behandeling met een op maat gemaakt dieet bij eosinofiele oesofagitis: “De IDEA-studie”

Eosinophilic oesophagitis (EoO) is an inflammatory disease of the oesophagus resulting in dysphagia, food impaction and strictures. Current treatment is limited to topical or systemic corticosteroids, dietary measures and repeated endoscopic dilations. The use of corticosteroids is accompanied by increased risks of infections and metabolic disorders such as osteoporosis while dilations have a substantial perforation risk.
We have already found that an impaired barrier function of the oesophageal epithelium plays a role in the pathophysiology of EoO, enabling passage of molecules with the size of food allergens through the epithelium and possibly causing immune activation. Since most EoO patients suffer from atopic diseases, it has been suggested that food allergens play a role in EoO. We believe that these food allergens can cross the epithelial barrier and therefore hypothesize that a diet based on broad-spectrum food allergen testing could decrease inflammation and reduce symptoms.

Objective: to demonstrate that food elimination therapy based on component-resolved diagnostics is an effective and acceptable treatment for EoO patients.

Study design: prospective proof of principle study.

Study population: patients diagnosed with EoO (≥15 eosinophils per HPF) aged 18-75 yrs with confirmed IgE-antibodies to at least 1 food allergen.

Intervention: in all patients with EoO and observed sensitization to aeroallergens and/or food allergens, a diet with exclusion of all foods to which the patient is sensitized is started. At baseline, after 6 weeks of dietary treatment and 6 weeks after reintroduction of foods, patients will undergo endoscopy with biopsies, and blood sampling, and they will fill in symptom questionnaires.

Main study parameters/endpoints:
Primary: Oesophageal eosinophilic infiltration at baseline and after dietary treatment, and after reintroduction of foods, as measured by the peak eosinophil count in the oesophageal mucosa.

Secondary: Symptoms of dysphagia and quality of life (SF-36 and the FAQLQ-AF questionnaire), endoscopic signs of EoO, oesophageal mastocytic infiltration, EoO biomarkers in serum and oesophageal tissue; validation of results ImmunoCAP ISAC allergy test results compared to standard skin prick test results.

An impaired barrier function of the oesophageal epithelium plays a role in the pathophysiology of EoO, enabling passage of molecules with the size of food allergens through the epithelium and possibly causing immune activation. Since most EoO patients suffer from atopic diseases, it has been suggested that food allergens play a role in EoO. We believe that these food allergens can cross the epithelial barrier and therefore hypothesize that a diet based on broad-spectrum food allergen testing could decrease inflammation and reduce symptoms.

t=0: stop immunosuppressants

t=8wks: endoscopy, start diet

t=14wks: endoscopy, food reintroduction

t=20wks: endoscopy, skin prick testing

Baseline endoscopy, followed by food elimination diet during 6 weeks and re-endoscopy. In responders, foods will be reintroduced during 6 weeks, followed by a third endoscopy