Targeted Elimination Diet in EoE Patients Following Identification of Trigger Nutrients Using Confocal Laser Endomicroscopy (CLE-EoE)
Eosinophilic Esophagitis
About this trial
This is an interventional diagnostic trial for Eosinophilic Esophagitis focused on measuring confocal laser endomicroscopy, 6-food elimination diet, personalized exclusion diet
Eligibility Criteria
Inclusion Criteria: Eosinophilic Esophagitis, with peak eosinophil count of >15 eos/HPF and symptoms of dysphagia at least 2 days per week Patients have had a trial of high-dose PPI for at least 8 weeks, with either documented non-response or intolerance to the medication Patients aged between 18 and 70 years old Signed written informed consent Eosinophilic Esophagitis, with peak eosinophil count of >15 eos/HPF and symptoms of dysphagia at least 2 days per week Patients have had a trial of high-dose PPI for at least 8 weeks, with either documented non-response or intolerance to the medication Patients aged between 18 and 70 years old Signed written informed consent Exclusion criteria: IgE-mediated food anaphylaxis for 1 of the trigger nutrients History of major gastrointestinal surgery complicating esophago-gastro-duodenoscopy Gastro-esophageal reflux disease (GERD) Los Angeles grade C or D Esophageal strictures, too narrow to pass with a normal gastroscope Endoscopic dilation in the esophagus in the 4 weeks prior to inclusion Celiac disease Recent 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 Propofol Pregnant or lactating women
Sites / Locations
- Jan TackRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Sham Comparator
Sham Comparator
CLE positive patients real/sham
CLE positive patients sham/real
CLE negative patients
In this arm, participants who reacted to one or two nutrients during CLE will follow a personalized exclusion diet consistent of the nutrient to which they reacted, after which they will follow a sham diet in a blinded cross-over fashion.
In this arm, participants who reacted to one or two nutrients during CLE will follow a sham diet for 6 weeks, and than a personalized exclusion diet consistent of the nutrient to which they reacted, in a blinded cross-over fashion.
In this arm, participants who did not react to one of the nutrients during CLE will follow a control diet consistent of milk exclusion for 6 weeks, after which they will follow a gluten exclusion diet for 6 weeks, or the other way around.