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

NCT05695456 | Recruiting Phase 1

• 1 other identifier: S66223
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Eosinophilic Esophagitis

Keywords

confocal laser endomicroscopy; 6-food elimination diet; personalized exclusion diet

Outcome Measures

Primary Outcomes (1)

• Difference in response

  Difference in response (defined as normalization of peak eosinophil count in esophageal mucosal biopsies \<15 eosinophils/HPF) in patients undergoing duodenal CLE-targeted elimination diet compared to the sham diet

  2 years

Secondary Outcomes (9)

• Further histological outcomes

  2 years

• Further histological outcomes

  2 years

• Symptomatic changes in patients undergoing duodenal CLE-targeted elimination diet compared to the sham diet

  2 years

• endoscopic changes in patients undergoing duodenal CLE-targeted elimination diet compared to the sham diet

  2 years

• change in esophageal and duodenal permeability parameters 1

  2 years

Study Arms (3)

CLE positive patients real/sham

ACTIVE COMPARATOR

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.

Other: personalized exclusion diet based on CLE

CLE positive patients sham/real

SHAM COMPARATOR

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.

Other: personalized exclusion diet based on CLE

CLE negative patients

SHAM COMPARATOR

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.

Other: empiric exclusion diet

Interventions

personalized exclusion diet based on CLE OTHER

personalized exclusion diet based on CLE

CLE positive patients real/sham; CLE positive patients sham/real

empiric exclusion diet OTHER

exclusion diet with milk or gluten-containing grains

CLE negative patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

Jan Tack

Leuven, Vlaams Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Jan Tack, MD PhD

CONTACT

+3216345514; jan.tack@kuleuven.be

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Nor the participant, nor the primary or secondary investigators involved in the study will know to which nutrients the patient reacted as assessed by CLE, nor will they know what the order of the diet is (sham or real). An investigator who did not participate in the CLE will give dietary instructions.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A double-blind cross-over dietary elimination study: Patients with a positive CLE reaction to one or two specific nutrients will then be randomized to a blinded exclusion diet for 6 weeks of those nutrients or to exclusion of another tested nutrient that yielded no change in CLE (=sham diet), in a cross-over fashion. Patients with no CLE reaction will undergo an empirical exclusion diet of gluten-containing grains for 6 weeks. To mirror the crossover character of the intervention, CLE negative patients will then undergo a milk exclusion diet for 6 weeks (order is interchangeable).

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: January 25, 2023
• Study Start: February 16, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 27, 2024

Record last verified: 2024-03

Locations

BE (1)