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Individually tailored Dietary treatment of Eosinophilic oesophagitis in Adults

Individually tailored Dietary treatment of Eosinophilic oesophagitis in Adults - IDEA-study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON39630
Enrollment
40
Registered
2013-03-20
Start date
2013-06-15
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

allergic esophagitis Eosinophilic esophagitis

Interventions

Exclusion diet based on allergy test

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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 * Age 18-75 years * Written informed consent

Exclusion criteria

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 Barrett*s oesophagus * History of GI cancer * History of GI tract surgery (except appendectomy or cholecystectomy) * ASA class IV or V

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Symptoms of dysphagia and quality of life (SF-36 and the FAQLQ-AF questionnaire), endoscopic signs of EoO, oesophageal mastocytic infiltration, serum levels of biomarkers for EoO (eosinophil count, total IgE, IL-5, IL-13, eotaxin-3, eosinophil derived neurotoxin [EDN]), oesophageal tissue biomarkers (e.g. IL-5, IL-13, eotaxin-3, periostin, TGF-bèta, filaggrin, phospho-MLCK). Validation of results of the ImmunoCAP ISAC allergy test compared to standard skin prick test results.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)