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Local Responses to Food Allergens in Eosinophilic Esophagitis: Mechanisms and Clinical Application

Local Responses to Food Allergens in Eosinophilic Esophagitis: Mechanisms and Clinical Application - LOIRE-trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON49025
Enrollment
18
Registered
2019-05-24
Start date
2019-08-14
Completion date
Unknown
Last updated
2024-04-15

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

EoE patients will undergo two gastroscopies with allergen provocation tests. In one gastroscopy patients undergo esophageal allergen injections as described in our pilot study (NL54305.018.15 / METC

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Eosinophilic esophagitis 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 - Written informed consent - Age 18-75 years Non- eosinophilic esophagitis patients - Patients that undergo a gastroscopy for other indications than esophageal complaints - Written informed consent - Age 18 * 75 years

Exclusion criteria

Exclusion criteria: Eosinophilic esophagitis 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 - ASA class III, IV or V - History of anaphylaxis - History of a severe systemic reaction to previous allergy tests (grade 3 or 4) Non- eosinophilic esophagitis patients - Symptoms of esophageal dysfunction - History of esophageal diseases

Design outcomes

Primary

MeasureTime frame
Visible response to allergen provocation in the esophagus, defined as early phase response

Secondary

MeasureTime frame
1. Immune response after allergen injection and flush of allergens, defined as activated immune cells observed in biopsies 2. Immune response to added allergens of esophageal mucosal cells in culture medium, defined as release of cytokines 3. Esophageal motility changes after allergen exposure

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)