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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Belgium
Jan Tack
RECRUITING
Leuven
Contact Information
Primary
Jan Tack, MD PhD
jan.tack@kuleuven.be
+3216345514
Time Frame
Start Date: 2022-02-16
Estimated Completion Date: 2024-12
Participants
Target number of participants: 25
Treatments
Active_comparator: CLE positive patients real/sham
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.
Sham_comparator: CLE positive patients sham/real
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.
Sham_comparator: CLE negative patients
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.
Sponsors
Leads: Universitaire Ziekenhuizen KU Leuven

This content was sourced from clinicaltrials.gov