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…
ID
Bron
Aandoening
Eosinophilic esophagitis, etiology, pathophysiology, epithelial barrier function, permeability, steroids, treatment, therapy.
Eosinofiele oesofagitis, etiologie, pathofysiologie, epitheliale barrierefunctie, permeabiliteit, steroiden, behandeling, therapie.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Tissue impedance, intercellular spaces, and mucosal permeability to small molecules before and after treatment with 500 µg fluticasone propionate twice daily for 8 weeks.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
At baseline and after 8 weeks of treatment with fluticasone.
Onderzoeksproduct en/of interventie
EoE patients will be treated with fluticasone 500 mcg bd for 8 weeks.
Algemeen / deelnemers
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
Wetenschappers
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3355 |
| NTR-old | NTR3487 |
| CCMO | NL39184.018.11 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON37559 |