|- candidate number||14977|
|- NTR Number||NTR4052|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-jun-2013|
|- Secondary IDs||METC-nr: NL42608.018.12 Individually tailored Dietary treatment of Eosinophilic oesophagitis in Adults|
|- Public Title||Behandeling met een op maat gemaakt dieet bij eosinofiele oesofagitis: De IDEA-studie|
|- Scientific Title||Individually tailored Dietary treatment of Eosinophilic oesophagitis in Adults|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Eosinophilic esophagitis, Food allergy, Diet, Serum IgE, ImmunoCAP ISAC|
|- Inclusion criteria|| Previous clinical diagnosis of EoO confirmed by histopathology e.g. presence of >15 eosinophilic granulocytes per high power field (hpf) in mid- or proximal-oesophageal biopsies |
(Cross-)sensitization against at least 1 food allergen as measured by ImmunoCAP ISAC (microarray)
Age 18 75 years
Written informed consent
|- Exclusion criteria|| Inability to stop previously started topical or systemic corticosteroids, leukotriene inhibitors, or monoclonal antibodies, in the two month period preceding and during the study|
Use of NSAIDs
History of peptic ulcer disease
History of Barretts oesophagus
History of GI cancer
History of GI tract surgery (except appendectomy or cholecystectomy)
ASA class IV or V.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-jul-2013|
|- planned closingdate||30-jun-2014|
|- Target number of participants||40|
|- Interventions||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|
|- Primary outcome||Peak eosinophilia in mucosal biopsies of proximal, mid- and distal oesophagus at baseline and after targeted dietary treatment defined as complete (peak eosinophil count, <5 eos/hpf), near complete (<10 eos/hpf), and partial (>50% reduction of peak eosinophil count). |
|- Secondary outcome|| Symptoms of dysphagia;|
Quality of life, as measured by the SF-36 and the FAQLQ-AF questionnaire;
Endoscopic signs of EoO;
Peak mastocytosis in mucosal biopsies of proximal, mid- and distal oesophagus;
Serum levels of biomarkers for EoO: eosinophil count, total IgE, IL-5, IL-13, eotaxin-3, eosinophil derived neurotoxin (EDN);
RNA-expression of biomarkers for EoO in oesophageal tissue;
Evaluation of dietary intake at baseline of EoO-patients
Comparison of results of the ImmunoCAP ISAC allergy test with standard skin prick test results.
|- Timepoints||t=0: stop immunosuppressants|
t=8wks: endoscopy, start diet
t=14wks: endoscopy, food reintroduction
t=20wks: endoscopy, skin prick testing
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD. B.D. Rhijn, van|
|- CONTACT for SCIENTIFIC QUERIES||MD. B.D. Rhijn, van|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC)|
|- Brief summary||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.
|- Main changes (audit trail)|
|- RECORD||11-jun-2013 - 8-jul-2013|