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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 22, 2025 (before its estimated October 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Primary completion date: Oct 2024 to Oct 2025 Completion date: Mar 2025 to Oct 2025v3 Show 1 more changeShow less
    • Completion date: Mar 2025 to Oct 2025
  2. Notable Primary completion date: Oct 2023 to Oct 2024 Completion date: Mar 2024 to Mar 2025v2 Show 1 more changeShow less
    • Completion date: Mar 2024 to Mar 2025
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05180578
Lead Sponsor Shaare Zedek Medical Center
Conditions Eosinophilic Esophagitis
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov