Oral Immunotherapy for Milk Allergy
Trial Summary
Do I need to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on immunosuppressive therapy or β-blockers (a type of medication often used for heart conditions).
What data supports the effectiveness of the treatment Oral Immunotherapy for Milk Allergy?
How does oral immunotherapy for milk allergy differ from other treatments?
Oral immunotherapy for milk allergy is unique because it gradually increases the amount of milk protein a person can consume without having an allergic reaction, effectively desensitizing them to milk. This approach is different from simply avoiding milk, as it aims to build tolerance over time.13467
What is the purpose of this trial?
This study will assess a novel and potentially life-changing therapy, by actively treating Cow's Milk Allergy (CMA) using Oral Immunotherapy, which may allow patients to safely consume milk and other dairy products.
Eligibility Criteria
This trial is for children with a confirmed milk allergy, either through skin tests or blood tests showing specific antibodies to milk proteins. They must have had symptoms of an allergic reaction to milk. Parents or guardians need to consent for participation. Children can't join if they're on immunosuppressive drugs, have heart issues that make epinephrine use risky, uncontrolled asthma, are taking beta-blockers, or have cancer/autoimmune diseases.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Initial Desensitization
Participants undergo a 2-day rush desensitization treatment using oral doses of milk
Dose Escalation
Participants continue the highest tolerated dose of milk at home for two weeks, followed by weekly increases in doses until a maximum of 200 ml of milk is ingested daily
Maintenance
Participants maintain the maximum tolerated dose of 200 ml of milk daily for one month
Follow-up
Participants are monitored for safety and effectiveness after treatment, including an open challenge to 300 ml of milk and a year-long follow-up period
Treatment Details
Interventions
- Oral Immunotherapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead Sponsor