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Oesophageal epithelial permeability changes in patients with eosinophilic oesophagitis

Oesophageal epithelial permeability changes in patients with eosinophilic oesophagitis - Oesophageal epithelial permeability changes in EoE

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON36166
Enrollment
22
Registered
2011-07-19
Start date
2011-09-02
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

idiopathic allergic oesophagitis

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Previous diagnosis of eosinophilic oesophagitis confirmed by histopathology e.g. presence of >15 eosinophilic granulocytes per high power field in mid-oesophageal biopsies before the start of any therapy 2. Written informed consent 3. Age 18 * 75 years

Exclusion criteria

Exclusion criteria: 1. Inability to stop topical corticosteroids 2. Inability to stop PPI, H2-receptor antagonist or prokinetic drug for 8 weeks 3. Use of systemic corticosteroids, leukotriene inhibitors, or monoclonal antibodies, in the 2 month period preceding the study 4. Use of oral anticoagulants 5. Use of NSAIDs 6. History of peptic ulcer disease 7. History of Barrett*s oesophagus 8. History of GI cancer 9. History of GI tract surgery (except appendectomy)

Design outcomes

Primary

MeasureTime frame
- Oesophageal intercellular spaces are dilated in EoE patients compared to healthy subjects. - Mucosal permeability to small molecules is increased in EoE patients compared to healthy subjects. - Tissue impedance measurement is affected in EoE patients compared to healthy subjects. - Dilated intercellular spaces correlate with affected tissue impedance and increased mucosal permeability to small molecules in EoE patients. - Affected tissue impedance correlates with increased mucosal permeability to small molecules in EoE patients. - Numbers of oesophageal intraepithelial eosinophils are increased in EoE patients compared to healthy subjects. - Numbers of oesophageal intraepithelial mast cells are increased in EoE patients compared to healthy subjects.

Secondary

MeasureTime frame
- Tissue impedance, dilation of intercellular spaces, increased mucosal permeability to small molecules, and numbers of oesophageal intraepithelial mast cells and eosinophils are reversible by 8 weeks administration of 40 mg esomeprazole twice daily. - The composition of inflammatory cells present in the esophageal biopsies - The number of reflux episodes

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)