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

Launched by SHAARE ZEDEK MEDICAL CENTER · Jan 5, 2022

Keywords

ClinConnect Summary

This clinical trial is studying whether goat milk can be safely consumed by patients with eosinophilic esophagitis (EoE) who have a known allergy to cow's milk. EoE is a condition where the esophagus, the tube that connects the throat to the stomach, becomes inflamed due to an immune response, often triggered by certain foods, especially cow's milk. The researchers want to find out if patients can tolerate goat milk without having a flare-up of their symptoms, which could make it easier for them to enjoy a wider variety of foods.

To participate, patients must be diagnosed with EoE and have a confirmed reaction to cow's milk. They should be between 0 and 17.5 years old and have shown improvement when cow's milk was removed from their diet. However, those with a severe allergy to milk or specific test results may not be eligible. Participants can expect to try goat milk under medical supervision and will be monitored closely for any reactions. This trial aims to provide new options for managing EoE while improving the quality of life for patients who struggle with restrictive diets.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • All patients diagnosed with EoE age ≤ 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.