Testing goat milk protein tolerance in patients with eosinophilic esophagitis triggered by cow milk
Tolerability of Goat Milk Protein in Eosinophilic Esophagitis Patients With Cow Milk Protein Trigger
NA · Shaare Zedek Medical Center · NCT05180578
This study is testing if people with eosinophilic esophagitis who can't tolerate cow milk can safely drink goat milk without having a bad reaction.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Shaare Zedek Medical Center (other) |
| Locations | 1 site (Jerusalem) |
| Trial ID | NCT05180578 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients aged 17.5 years or younger diagnosed with eosinophilic esophagitis and confirmed to have cow's milk as a trigger.
Not a fit: Patients with clinical IgE-mediated milk allergy or those who test positive for cow milk allergens will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an alternative dietary option for patients with eosinophilic esophagitis who are sensitive to cow milk.
How similar studies have performed: While there is limited data on the cross-reactivity of milk from different species, similar dietary interventions have shown promise in managing eosinophilic esophagitis.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Jerusalem
- Shaare Zedek — Jerusalem, Israel (RECRUITING)
Study contacts
- Study coordinator: Oren Ledder, Dr.
- Email: orenl@szmc.org.il
- Phone: +972-2-6666743
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Eosinophilic Esophagitis, EOE