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

StatusEnrolling by Invitation
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Trial status: Not Yet Recruiting to Enrolling by Invitation Study sites: 0 to 1 · Start date changed from estimate of Mar 2025 to Mar 1, 2025v4 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 2025 to Mar 1, 2025
  2. Minor Secondary endpoints: details revised at 1 of 4 entriesv3
  3. Minor Secondary endpoints: details revised at 2 of 4 entriesv2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 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.
Trial Details
NCT Number NCT06756581
Lead Sponsor Shaare Zedek Medical Center
Conditions Eosinophilic Esophagitis (EoE)
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov