Eosinophilic esophagitis, treatment, elemental diet, amino acid based formula, eosinophils, gastrointestinal barrier function
Conditions
Interventions
Elemental diet preceded by and followed by gastroscopy, vena puncture, salive, feces and urine analysis.
Sponsors
Academic Medical Center, Amsterdam, The Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: - Previous diagnosis of EoE confirmed by histopathology e.g. presence of >15 eosinophilic granulocytes per high power field (hpf) in mid or proximal esophageal biopsies before the start of any therapy - Currently experiencing dysphagia - Written informed consent - Age 18 – 75 years Healthy controls: - Written informed consent - Age 18 – 75 years
Exclusion criteria
Exclusion criteria: Patients: - Inability to stop topical corticosteroids - Use of systemic corticosteroids, leukotriene inhibitors, or monoclonal antibodies, in the month preceding the study - Use of anticoagulants at study entry - Use of NSAIDs without possibility to stop - History of peptic ulcer disease - History of Barrett’s esophagus - History of GI cancer - History of GI tract surgery (except appendectomy) - ASA class IV or V Healthy controls: - Use of systemic corticosteroids, leukotriene inhibitors, or monoclonal antibodies in the month preceding the study - Use of anticoagulants at study entry - Use of NSAIDs without possibility to stop - Personal history of atopic, skin or systemic diseases - Symptoms suggestive of esophageal disease - History of GI cancer - History of GI tract surgery (except appendectomy) - History of PPI, H2-receptor antagonist, or prokinetic drug use - ASA class IV or V
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in esophageal mucosalpeak eosinophil count, measured as maximum number of eosinophils per hpf. Response is defined as complete when the peak eosinophil count decreases to <15 eos/hpf. | — |
Secondary
| Measure | Time frame |
|---|---|
| Measures of mucosal barrier function: - Esophageal and duodenal permeability measured in vivo (electrical tissue impedance spectroscopy) and ex vivo (Ussing chambers experiments) - Intestinal permeability testing using a PEG absorption – Urine excretion test Clinical parameters: - Questionnaires - Symptoms (dysphagia, food impaction) (Baseline and after 4 week) - Patient acceptation of and adherence to the diet (every week) - Quality of life (SF-36) Baseline and after 4 weeks - Endoscopic features - Correlation between primary/secondary parameters and intestinal permeability - Adherence to the diet - Empty drink packages will be stored by the patient and they will be asked to note the date of consumption on it - A questionnaire “Studie productinname” will be filled in weekly Laboratory investigations: - Immunohistochemical analyses of esophageal and duodenal biopsy material to assess expression and localization of proteins involved in barrier function - Serum biomarkers (total IgE, eosinophil count, IL-5, IL-13, eotaxin-3, eosinophil-derived neurotoxin) - Transcriptional analyses: microarray or focused qPCR. Genes to be analyzed by qPCR involve: - Activity markers of EoE (IL-5, IL-13, eotaxin-3, TGF-B) - Tight junction proteins (Claudins, ZO-3, occludin, filaggrin, desmoglein) - Inflammatory genes (IL-6, IL-10, TNFá, CCL-2, CCL-5, CCL-20, LAG3, ICAM1, caspases 1-14) - If other assessments show differences between the groups optionally the gastrointestinal microbiome will be analyzed. | — |
Contacts
Public ContactM. Warners
Research fellow
Outcome results
None listed