Oesophageal epithelial permeability changes in patients with eosinophilic oesophagitis
Completed
- Conditions
- idiopathic allergic oesophagitis1001796910001708
- Registration Number
- NL-OMON36166
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 22
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
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)
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Oesophageal intercellular spaces are dilated in EoE patients compared to<br /><br>healthy subjects.<br /><br>- Mucosal permeability to small molecules is increased in EoE patients compared<br /><br>to healthy subjects.<br /><br>- Tissue impedance measurement is affected in EoE patients compared to healthy<br /><br>subjects.<br /><br>- Dilated intercellular spaces correlate with affected tissue impedance and<br /><br>increased mucosal permeability to small molecules in EoE patients.<br /><br>- Affected tissue impedance correlates with increased mucosal permeability to<br /><br>small molecules in EoE patients.<br /><br>- Numbers of oesophageal intraepithelial eosinophils are increased in EoE<br /><br>patients compared to healthy subjects.<br /><br>- Numbers of oesophageal intraepithelial mast cells are increased in EoE<br /><br>patients compared to healthy subjects.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Tissue impedance, dilation of intercellular spaces, increased mucosal<br /><br>permeability to small molecules, and numbers of oesophageal intraepithelial<br /><br>mast cells and eosinophils are reversible by 8 weeks administration of 40 mg<br /><br>esomeprazole twice daily.<br /><br>- The composition of inflammatory cells present in the esophageal biopsies<br /><br>- The number of reflux episodes</p><br>