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Recruiting NCT05695456

Targeted Elimination Diet in EoE Patients Following Identification of Trigger Nutrients Using Confocal Laser Endomicroscopy

Conditions: Eosinophilic Esophagitis

Sex: All
Ages: 18 Years – 70 Years
Phase: PHASE1, PHASE2
Enrollment: 25
Sponsor: Universitaire Ziekenhuizen KU Leuven

Location: Belgium

Summary

Using confocal laser endomicroscopy (CLE), gastrointestinal allergic reactions to certain foods in the duodenum will be evaluated on a cellular level. After that, a personalized exclusion diet will be followed based on the CLE results for 6 weeks, sham-controlled, in a cross-over fashion. Gastroscopy with esophageal biopsies will be repeated after each diet.

Eligibility Criteria

Inclusion Criteria:Eosinophilic Esophagitis, with peak eosinophil count of >15 eos/HPF and symptoms of dysphagia at least 2 days per weekPatients have had a trial of high-dose PPI for at least 8 weeks, with either documented non-response or intolerance to the medicationPatients aged between 18 and 70 years oldSigned written informed consentEosinophilic Esophagitis, with peak eosinophil count of >15 eos/HPF and symptoms of dysphagia at least 2 days per weekPatients have had a trial of high-dose PPI for at least 8 weeks, with either documented non-response or intolerance to the medicationPatients aged between 18 and 70 years oldSigned written informed consentExclusion criteria:IgE-mediated food anaphylaxis for 1 of the trigger nutrientsHistory of major gastrointestinal surgery complicating esophago-gastro-duodenoscopyGastro-esophageal reflux disease (GERD) Los Angeles grade C or DEsophageal strictures, too narrow to pass with a normal gastroscopeEndoscopic dilation in the esophagus in the 4 weeks prior to inclusionCeliac diseaseRecent use (within two weeks) of non-steroidal anti-inflammatory drugs (NSAIDs), systemic histamine-receptor antagonists, mast cell stabilizers, opioids.Proton pump inhibitors must be either stopped for at least 4 weeks, or continued on a stable dosage throughout the study period.Corticosteroids should be stopped for at least 4 weeks.Allergy to fluorescein, Xylocain or PropofolPregnant or lactating women

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Source: ClinicalTrials.gov (NCT05695456). StuddyBuddy aggregates publicly available trial information.