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Hypersensitivity in Eosinophilic Esophagitis

Hypersensitivity in Eosinophilic Esophagitis - SENSEoE-trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON49677
Enrollment
17
Registered
2020-01-31
Start date
2020-11-24
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

An acid perfusion test and barostat balloon distention test will be performed in EoE patients at baseline. This will be repeated in the EoE patients after 6-8 weeks of topical budesonide standard tr

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Previous diagnosis of active EoE confirmed by histopathology e.g. presence of >15 eosinophilic granulocytes per high power field (hpf) in esophageal biopsies - Written informed consent - Age 18-75 years

Exclusion criteria

Exclusion criteria: - Any form of treatment for EoE (topical corticosteroids, PPI or dietary treatment) in the month preceding the study - ASA class III, IV or V - The need for pain medication 24 hours before the visit

Design outcomes

Primary

MeasureTime frame
Measures of sensitivity of the esophagus: 1. Perfusion sensitivity scores in histological active disease, disease in remission and healthy controls, calculated via [(total perfusion time * lag time to perception) x maximum VAS] 2. Balloon pressure that induced a sensation of discomfort in histological active disease, disease in remission and healthy controls

Secondary

MeasureTime frame
1. Esophageal barrier function in histological active disease and disease in remission, defined as electrical tissue impedance measured with ETIS and transepithelial electrical resistance and fluorescein flux measured in Ussing chamber 2. The degree of reflux in the EoE patients, as measured with 24-hours pH- impedance measurement

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)