Tolerability of Baked Dairy Protein in Eosinophilic Esophagitis Patients With Cow Milk Protein Trigger

NCT06756581 | Enrolling By Invitation

• 1 other identifier: EoE tolerability of baked milk
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Eosinophilic esophagitis (EoE) is a chronic immune mediated disease characterized by eosinophilic infiltration in esophageal epithelium and resulting in esophageal dysfunction. While the exact pathogenesis is yet to be elucidated, EoE is considered an atopic disease. This classification is in part due to the inflammatory infiltrate of eosinophils, basophils and T-cells producing Th2 cytokines, yet it may also be triggered by environmental allergens. In addition, the rates of atopy are approximately 3 times higher in patients with EoE than in the general population. Furthermore, and most convincing, EoE is successfully managed with dietary exclusion of triggering groups in both pediatric and adult patients, further confirming the atopic nature of the disease. The most frequent dietary trigger for EoE is milk, but there is limited data on the effect of baked dairy . Guidelines addressing the diagnosis and treatment of EoE in both children and adults have not addressed the use of baked dairy in patients with cow's milk triggered EoE. Restrictive diets are often challenging for patients and contribute to a reduced quality of life. Some patients tolerate baked dairy products, which are less allergenic due to denaturation of proteins through heat. The potential for baked dairy to be included in the diet of milk-triggered EoE patients remains unexplored in current guidelines. The aim of this study is to assess tolerability and safety of baked dairy in patients with EoE in whom cow's milk has been confirmed to be a trigger food for their disease.

Conditions

Eosinophilic Esophagitis (EoE)

Keywords

Eosinophilic Esophagitis (EoE)

Outcome Measures

Primary Outcomes (1)

• Histologic remission rate following 12 weeks exposure to ingested baked dairy products

  will be assessed on biopsies collected at week 12 during upper endoscopy

  12 weeks exposure to ingested baked dairy products

Secondary Outcomes (4)

• Symptom scores following 12 weeks exposure to ingested baked dairy

  12 weeks exposure to ingested baked dairy

• Endoscopic remission rate following 12 weeks exposure to ingested baked dairy

  2 weeks exposure to ingested baked dairy

• Endoscopic improvement following 12 weeks exposure to ingested baked dairy

  12 weeks exposure to ingested baked dairy

• Safety of cow's milk challenge

  36 months

Study Arms (1)

Tolerability of baked milk products in eosinophilic esophagitis patients with cow milk trigger

EXPERIMENTAL

Elimination of none baked cow milk from diet . Baked milk products containing diet.

Other: baked milk product diet

Interventions

baked milk product diet OTHER

Elimination of none baked cow milk from diet . Baked cow milk containing diet.

Tolerability of baked milk products in eosinophilic esophagitis patients with cow milk trigger

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Verified histologic remission on milk-free diet on endoscopy prior to intervention
• Proton-pump inhibitors may be used if treatment is maintained at the same dose from the screening endoscopy throughout the trial period, and was used at the time that milk was demonstrated to be the triggering food
• Ability to consent to enrollment in the trial - legal guardians with joint consent for patients \>10 years.

You may not qualify if:

• Patients with clinical IgE-mediated milk allergy
• Use of inhaled corticosteroids for more than 5 days per month during the trial period.

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Oren Ledder, Principal Investigator

Study Record Dates

• First Submitted: December 26, 2024
• First Posted: January 3, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 22, 2025

Record last verified: 2025-05

Locations

IL (1)