To demonstrate that food elimination therapy based on component-resolved diagnostics is an effective and acceptable treatment for EoO patients.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
- Allergic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Oesophageal eosinophilic infiltration at baseline and after dietary treatment,
and after reintroduction of foods, as measured by the peak eosinophil count in
the oesophageal mucosa.
Secondary outcome
Symptoms of dysphagia and quality of life (SF-36 and the FAQLQ-AF
questionnaire), endoscopic signs of EoO, oesophageal mastocytic infiltration,
serum levels of biomarkers for EoO (eosinophil count, total IgE, IL-5, IL-13,
eotaxin-3, eosinophil derived neurotoxin [EDN]), oesophageal tissue biomarkers
(e.g. IL-5, IL-13, eotaxin-3, periostin, TGF-bèta, filaggrin, phospho-MLCK).
Validation of results of the ImmunoCAP ISAC allergy test compared to standard
skin prick test results.
Background summary
Eosinophilic oesophagitis (EoO) is an inflammatory disease of the oesophagus
resulting in dysphagia, food impaction and strictures. Current treatment is
limited to topical or systemic corticosteroids, dietary measures and repeated
endoscopic dilations. The use of corticosteroids is accompanied by increased
risks of infections and metabolic disorders such as osteoporosis while
dilations have a substantial perforation risk.
We have already found that an impaired barrier function of the oesophageal
epithelium plays a role in the pathophysiology of EoO, enabling passage of
molecules with the size of food allergens through the epithelium and possibly
causing immune activation. Since most EoO patients suffer from atopic diseases,
it has been suggested that food allergens play a role in EoO. We believe that
these food allergens can cross the epithelial barrier and therefore hypothesize
that a diet based on broad-spectrum food allergen testing could decrease
inflammation and reduce symptoms.
Study objective
To demonstrate that food elimination therapy based on component-resolved
diagnostics is an effective and acceptable treatment for EoO patients.
Study design
Prospective proof of principle study.
Intervention
Exclusion diet based on allergy test
Study burden and risks
Burden and risk: Endoscopy with biopsy taking and blood sampling will be
performed three times. Endoscopy is associated with a very low risk of
perforation. Skin prick tests may lead to anaphylaxis; for this reason these
tests will be performed by an experienced clinical allergologist in the AMC.
Benefit: Patients will be tested for allergies using techniques that are not
(yet) available for routine clinical care and will consult an allergy
specialist dietician to get dietary advice based on this result.
Meibergdreef 9
Amsterdam 1100 DD
NL
Meibergdreef 9
Amsterdam 1100 DD
NL
Listed location countries
Age
Inclusion criteria
* Previous clinical diagnosis of EoO confirmed by histopathology e.g. presence of >15 eosinophilic granulocytes per high power field (hpf) in mid- or proximal-oesophageal biopsies
* (Cross-)sensitization against at least 1 food allergen as measured by ImmunoCAP ISAC
* Age 18-75 years
* Written informed consent
Exclusion criteria
* Inability to stop previously started topical or systemic corticosteroids, leukotriene inhibitors, or monoclonal antibodies, in the two month period preceding and during the study
* Use of NSAIDs
* History of peptic ulcer disease
* History of Barrett*s oesophagus
* History of GI cancer
* History of GI tract surgery (except appendectomy or cholecystectomy)
* ASA class IV or V
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL42608.018.12 |