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

Individually tailored Dietary treatment of Eosinophilic oesophagitis in Adults

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27096

Enrollment

Registered

2013-06-11

Start date

2013-07-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Eosinophilic oesophagitis, food allergy, diet, ImmunoCAP ISAC, serum IgE. Eosinofiele oesofagitis, voedselallergie, dieet, ImmunoCAP ISAC, serum IgE.

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

Eligibility

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 (microarray) • 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

Measure	Time frame
Peak eosinophilia in mucosal biopsies of proximal, mid- and distal oesophagus at baseline and after targeted dietary treatment defined as complete (peak eosinophil count, 50% reduction of peak eosinophil count).	—

Secondary

Measure	Time frame
• 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.	—

Measure

Time frame

• 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.

—

Contacts

Public ContactB.D. Rhijn, van

Motility Center, room C2-231 Academic Medical Center PO Box 22660

b.d.vanrhijn@amc.uva.nl+31 (0)20 5665584

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)