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Effects of topical steroids in patients with eosinophilic esophagitis (EoE).


- candidate number12905
- NTR NumberNTR3487
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-jun-2012
- Secondary IDsNL39184.018.11 CCMO
- Public TitleEffects of topical steroids in patients with eosinophilic esophagitis (EoE).
- Scientific TitleEffects of topical steroids on esophageal epithelial permeability and inflammation in patients with eosinophilic esophagitis (EoE).
- ACRONYM
- hypothesisAn 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.
- Healt Condition(s) or Problem(s) studiedEosinophilic esophagitis, Etiology, Pathophysiology, Epithelial barrier integrity, Permeability, Treatment, Therapy, Steroids
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 29-feb-2012
- planned closingdate1-feb-2013
- Target number of participants12
- InterventionsEoE patients will be treated with fluticasone 500 mcg bd for 8 weeks.
- Primary outcomeTissue impedance, intercellular spaces, and mucosal permeability to small molecules before and after treatment with 500 µg fluticasone propionate twice daily for 8 weeks.
- Secondary outcomeNumbers of esophageal intraepithelial eosinophils and mast cells before and after treatment with 500 µg fluticasone propionate twice daily for 8 weeks.
- TimepointsAt baseline and after 8 weeks of treatment with fluticasone.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. B.D. Rhijn, van
- CONTACT for SCIENTIFIC QUERIESMD. B.D. Rhijn, van
- Sponsor/Initiator Academic Medical Center (AMC, Amsterdam)
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryAn 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.
- Main changes (audit trail)
- RECORD18-jun-2012 - 1-jul-2012


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