No registrations found.
ID
Source
Health condition
Eosinophilic esophagitis, etiology, pathophysiology, epithelial barrier function, permeability, steroids, treatment, therapy.
Eosinofiele oesofagitis, etiologie, pathofysiologie, epitheliale barrierefunctie, permeabiliteit, steroiden, behandeling, therapie.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Tissue impedance, intercellular spaces, and mucosal permeability to small molecules before and after treatment with 500 µg fluticasone propionate twice daily for 8 weeks.
Secondary outcome
Numbers of esophageal intraepithelial eosinophils and mast cells before and after treatment with 500 µg fluticasone propionate twice daily for 8 weeks.
Background summary
An impaired epithelial barrier function is suggested to play a role in the pathophysiology of EoE. Standard treatment is with topical corticosteroids. EoE patients will be treated with swallowed fluticasone aerosole for 8 weeks. Endoscopy will be performed at baseline and after steroid therapy, to determine the effect on several epithelial barrier function parameters and eosinophilia.
Study objective
An impaired epithelial barrier function is suggested to play a role in the pathophysiology of EoE. Standard treatment with topical corticosteroids results in a reduction of symptoms and esophageal eosinophilia. We hypothesize that by treating EoE patients with swallowed fluticasone propionate, the esophageal epithelial barrier function could be restored. The effect of topical corticosteroid therapy on the epithelial barrier function has never been investigated before.
Study design
At baseline and after 8 weeks of treatment with fluticasone.
Intervention
EoE patients will be treated with fluticasone 500 mcg bd for 8 weeks.
Academic Medical Center<br>
PO Box 22660
B.D. Rhijn, van
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5665584
b.d.vanrhijn@amc.uva.nl
Academic Medical Center<br>
PO Box 22660
B.D. Rhijn, van
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5665584
b.d.vanrhijn@amc.uva.nl
Inclusion criteria
1. Previous diagnosis of EoE confirmed by histopathology e.g. presence of >15 eosinophilic granulocytes per high power field (hpf) in mid-esophageal biopsies before the start of any therapy;
2. Written informed consent;
3. Age 18 – 75 years.
Exclusion criteria
1. Inability to stop PPI, H2-receptor antagonist or prokinetic drug for 8 weeks;
2. Use of systemic corticosteroids, leukotriene inhibitors, or monoclonal antibodies, in the two month period preceding the study;
3. Use of anticoagulants;
4. Use of NSAIDs;
5. History of Barrett’s esophagus;
6. History of upper GI tract surgery;
7. ASA class IV or V.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3355 |
| NTR-old | NTR3487 |
| CCMO | NL39184.018.11 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON37559 |