Actively Recruiting

Phase Not Applicable
Age: 0 - 18Years
All Genders
NCT05180578

Tolerability of Goat Milk Protein in Eosinophilic Esophagitis Patients With Cow Milk Protein Trigger

Led by Shaare Zedek Medical Center · Updated on 2025-05-22

20

Participants Needed

1

Research Sites

254 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 cross-reactivity of milk from other species. Guidelines addressing the diagnosis and treatment of EoE in both children and adults have not addressed the use of non-bovine milk in patients with cow's milk triggered EoE. Restrictive diets are often challenging for patients and contribute to a reduced quality of life. Our own, anecdotal experience in two patients with milk triggered EoE who requested to introduce goat's milk into the patients' diet were that reintroduction did not trigger a clinical or histological flare of EoE. These cases of successful introduction of non-bovine milk introduces the possibility that a milk-free diet need not necessarily be exclusive of all species. The aim of this study is to assess tolerability and safety of goat's milk in patients with EoE in whom cow's milk has been confirmed to be a trigger food for their disease.

CONDITIONS

Official Title

Tolerability of Goat Milk Protein in Eosinophilic Esophagitis Patients With Cow Milk Protein Trigger

Who Can Participate

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with eosinophilic esophagitis age 17.5 years or younger
  • Confirmed cow's milk as a trigger by symptom improvement during elimination and relapse after reintroduction
  • Verified histologic remission on a milk-free diet before starting the study
  • Use of proton-pump inhibitors allowed if dose is stable and was used when milk was identified as trigger
  • Ability to provide consent; legal guardians with joint consent for patients older than 10 years
Not Eligible

You will not qualify if you...

  • Patients with clinical IgE-mediated milk allergy
  • Patients with positive RAST or skin-prick test to cow or goat milk without allergist clearance
  • Use of inhaled corticosteroids more than 5 days per month during the trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Shaare Zedek

Jerusalem, Israel, 91031

Actively Recruiting

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Research Team

O

Oren Ledder, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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