Testing goat milk protein tolerance in patients with eosinophilic esophagitis triggered by cow milk

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the tolerability of goat milk protein in patients diagnosed with eosinophilic esophagitis (EoE) who have identified cow milk as a dietary trigger. Participants will undergo a thorough screening process, including endoscopy and allergy testing, to ensure they are suitable candidates for the trial. Following a strict milk-free diet, patients will be introduced to a goat milk diet to assess their tolerance and any potential allergic reactions. The study will monitor symptoms and histological changes through follow-up endoscopies.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shaare Zedek
  Jerusalem, Israel Recruiting

Study contacts

• Study coordinator: Oren Ledder, Dr.
• Email: orenl@szmc.org.il
• Phone: +972-2-6666743

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.