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โ† Trials
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Tolerability of Goat Milk Protein in Eosinophilic Esophagitis Patients With Cow Milk Protein Trigger

RecruitingNAAges any - 18 YearsAllShaare Zedek Medical Center
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * All patients diagnosed with EoE age โ‰ค 17.5 years at inclusion who were confirmed to have cow's milk as a trigger by demonstrating improvement during elimination and histologic relapse following reintroduction. * 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. Exclusion Criteria: * Patients with clinical IgE-mediated milk allergy. * Provisional exclusion: patients without a known IgE-mediated allergic reaction to milk who have a positive RAST (as per local reference range) or positive skin-prick test for cow milk or goat milk must be assessed by a certified allergist/immunologist and cleared for the trial by a supervised goat milk challenge. * Use of inhaled corticosteroids for more than 5 days per month during the trial period.
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What it tests

  • Goat milk diet
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Where

1 site
Shaare Zedek
Jerusalem, Israel
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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