Skip to content

Gastroscopic Esophageal Prick Test in adult Eosinophilic Esophagitis Patients: a pilot study

Gastroscopic Esophageal Prick Test in adult Eosinophilic Esophagitis Patients: a pilot study - EPT trial

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON42606
Enrollment
12
Registered
2015-09-23
Start date
2016-01-05
Completion date
Unknown
Last updated
2024-06-11

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

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients -Previous diagnosis of active EoE confirmed by histopathology e.g. presence of >15 eosinophilic granulocytes per high power field (hpf) in mid or proximal esophageal biopsies -Macroscopic disease remission or significant mucosal healing after four weeks of treatment with an elemental or elimination diet -Written informed consent -Age 18 * 75 years;Healthy control group - Written informed consent - Age 18 * 75 years - Absence of atopic diseases - Absence of gastrointestinal symptoms

Exclusion criteria

Exclusion criteria: Patients - Inability to stop topical corticosteroids - Inability to stop beta-blockers and ACE inhibitors - Use of oral or systemic antihistaminics, oral cromoglicates, systemic corticosteroids, leukotriene inhibitors, or monoclonal antibodies, in the month preceding the study - Proven gastroesophageal reflux disease or other cause for esophageal eosinophilia - History of peptic ulcer disease - History of Barrett*s esophagus - History of GI cancer - History of GI tract surgery (except appendectomy) - ASA class III, IV or V - History of anaphylaxis - History of a severe systemic reaction to previous allergy tests (grade 3 or 4);Healthy controls - History of atopic diseases - Inability to stop beta-blockers and ACE inhibitors - Use of oral or systemic antihistaminics, oral cromoglicates, systemic corticosteroids, leukotriene inhibitors, or monoclonal antibodies, in the month preceding the study - Proven gastroesophageal reflux disease or other cause for esophageal eosinophilia - History of peptic ulcer disease - History of Barrett*s esophagus - History of GI cancer - History of GI tract surgery (except appendectomy) - ASA class III, IV or V - History of anaphylaxis - History of a severe systemic reaction to previous allergy tests (grade 3 or 4)

Design outcomes

Primary

MeasureTime frame
1. Visible immune response to allergens injected into the esophageal mucosa, defined as wheal and flare reaction. 2. In vitro immune response of esophageal mucosal tissue in culture medium to added allergenic solutions, defined as release of inflammatory cytokines, histamine and tryptase.

Secondary

MeasureTime frame
Clinical parameters: - Symptom-Based Activity Index EoE (EEsAI) - General allergy questionnaire - Correlation between clinical symptoms and positive wheal and flare reactions - Evaluation allergic / atopic history Sensitization patterns on standard allergy testing: - Skin Prick test - Allergen specific serum IgE testing (ImmunoCap) Endoscopic evaluation: - Endoscopic features (recorded by video and still images) - Delayed esophageal hypersensitivity reaction (wheal and flare after 24 hours) Measures of mucosal barrier function: - Esophageal intestinal mucosal integrity measured in vivo by electrical tissue impedance spectroscopy before and after allergen injection Laboratory investigations EPT and after in vitro allergen provocation: - Histological evaluation of two esophageal biopsies to determine peak eosinophil count and mast cell counts after dietary treatment - Local allergen-specific IgE production, measured as percent of tissue area labeled by IgE-positive cells in the biopsy specimens - Esophageal immune activation (eosinophil, mast cells and inflammatory cytokines histamine and tryptase counts)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)