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

NCT ID: NCT05695456

Last Updated: 2024-06-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-16
• Study Completion Date: 2024-12-31

Brief 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.

Detailed Description

Eosinophilic esophagitis is an antigen driven esophagitis, that is characterized by symptoms of dysphagia often leading to food impaction, and that leads to strictures and esophageal motility disorders, with a significant impact on quality of life. Current treatment options include proton pump inhibitors (PPI's) and topical steroids, and also the empiric 6-food elimination diet (6FED). In this diet, the 6 most frequently implicated foods are excluded and reintroduced one by one (milk, gluten containing grains, egg, soy, nuts, fish & shellfish). However, this is a complicated and long process, including several endoscopies with esophageal biopsies.

Confocal laser endomicroscopy (CLE) is a technique that allows to detect gastrointestinal allergic reactions in the duodenum, and to visualize them on a molecular level in real-time. The CLE probe is passed through the working channel of a standard gastroscope, up against the duodenal mucosa. After intravenous injection of fluorescein as contrast medium, the duodenal epithelium is visualized on a cellular level, including food protein mediated extravasation of fluorescein into the lumen. The 6 foods of the 6FED are sprayed on the epithelium one by one, after which a reaction is awaited. Previous use of CLE has shown that more than half of Eosinophilic esophagitis (EoE) patients reacts to one or more foods during CLE.

In this double blind randomized cross-over study the effect a personalized elimination diet, based on the reaction during CLE, is compared to a sham diet, in patients with eosinophilic esophagitis, and insufficient response or intolerance to PPI's. Both diets will be followed for 6 weeks, after which gastroscopy with esophageal biopsies will be repeated. Patients that do not have a reaction to the 6 foods will act as controls, following a control diet with milk and gluten in a cross-over fashion.

Conditions

Eosinophilic Esophagitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

personalized exclusion diet based on CLE

Intervention Type: OTHER

personalized exclusion diet based on CLE

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.

Group Type: SHAM_COMPARATOR

personalized exclusion diet based on CLE

Intervention Type: OTHER

personalized exclusion diet based on CLE

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.

Group Type: SHAM_COMPARATOR

empiric exclusion diet

Intervention Type: OTHER

exclusion diet with milk or gluten-containing grains

Interventions

personalized exclusion diet based on CLE

personalized exclusion diet based on CLE

Intervention Type: OTHER

empiric exclusion diet

exclusion diet with milk or gluten-containing grains

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jan Tack

Leuven, Vlaams Brabant, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Jan Tack, MD PhD

Role: CONTACT

jan.tack@kuleuven.be

+3216345514

Facility Contacts

Jan Tack, MD PhD

Role: primary

jan.tack@kuleuven.be

+3216345514

Other Identifiers

S66223

Identifier Type: -

Identifier Source: org_study_id