Oral Immunotherapy for Milk Allergy

Overseen By Jennifer Lee

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Must not be taking: Immunosuppressants, Beta-blockers

Disqualifiers: Uncontrolled asthma, Autoimmune diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

84 Participants Needed

What You Need to Know Before You Apply

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.

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).

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. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Oral Immunotherapy for Milk Allergy?

Research shows that oral immunotherapy for cow's milk allergy can effectively increase the amount of milk protein a person can consume without having an allergic reaction, making it a promising treatment option. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

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

The presence of at least one of the following confirmatory tests: (a) Positive skin prick test to milk (weal diameter 3 mm larger than that of the normal saline control) or (b) Detection of serum specific IgE (>0.35 kU/L) to milk or any of its proteins

Informed consent form signed by the parents or legal guardian

A history suggestive of IgE-mediated allergy to milk with specific symptoms criteria

Exclusion Criteria

I do not have heart disease or severe high blood pressure.

I have no history of cancer, autoimmune diseases, or severe immune deficiencies.

I am currently on medication that suppresses my immune system.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Desensitization

Participants undergo a 2-day rush desensitization treatment using oral doses of milk

2 days

1 visit (in-person)

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

2 weeks initial, followed by weekly visits

Weekly visits (in-person)

Maintenance

Participants maintain the maximum tolerated dose of 200 ml of milk daily for one month

1 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

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Oral Immunotherapy

Trial Overview The study is testing Oral Immunotherapy as a treatment for Cow's Milk Allergy (CMA). The goal is to see if this therapy allows children with CMA to safely consume dairy products without having allergic reactions.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Following randomization, participants in this group will receive escalating doses milk, up to a daily dose of 200 ml. Once they attain that dose, they will maintain it for one month. At the end of this period, they will undergo a open challenge to 300 ml of milk. They will then enter a year-long follow-up period

Group II: Control Active Control 1 Intervention

Following randomization, this arm will receive no intervention. After twelve months, participants in this group will undergo a singe-blind, placebo-controlled oral food challenge

Who Is Running the Clinical Trial?

McGill University Health Centre/Research Institute of the McGill University Health Centre

Lead Sponsor

Trials

476

Recruited

170,000+

Published Research Related to This Trial

In a study of 31 children with egg allergies, oral immunotherapy (OIT) led to desensitization in 94% of participants, indicating it is an effective treatment for this condition.

After a 3-month egg avoidance period, only 31% of those desensitized maintained tolerance, suggesting that while OIT is effective for desensitization, long-term tolerance may not be guaranteed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral Immunotherapy for Egg Allergy: A Double-Blind Placebo-Controlled Study, with Postdesensitization Follow-Up. Caminiti, L., Pajno, GB., Crisafulli, G., et al.[2015]

In a study of 68 children undergoing oral immunotherapy (OIT) for food allergies, about 90% were able to complete the treatment successfully, indicating that OIT can be effective for desensitization.

However, 9% of the children experienced severe adverse events (AEs) leading to discontinuation of the therapy, highlighting the importance of careful monitoring and the need for OIT to be conducted by trained professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile of oral immunotherapy with cow's milk and hen egg: A 10-year experience in controlled trials. Pajno, GB., Caminiti, L., Chiera, F., et al.[2017]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Oral immunotherapy in severe cow's milk allergic patients treated with omalizumab: Real life survey from a Spanish registry. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Oral Immunotherapy for Egg Allergy: A Double-Blind Placebo-Controlled Study, with Postdesensitization Follow-Up. [2015]

3. Denmark pubmed.ncbi.nlm.nih.gov

Long-term changes in milk component immunoglobulins reflect milk oral immunotherapy outcomes in Finnish children. [2023]

4. Turkey pubmed.ncbi.nlm.nih.gov

Oral Immunotherapy for Cow’s Milk Allergy: Five Years’ Experience from a Single Center in Turkey [2021]

5. England pubmed.ncbi.nlm.nih.gov

Life-threatening anaphylaxis in children with cow's milk allergy during oral immunotherapy and after treatment failure. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Safety profile of oral immunotherapy with cow's milk and hen egg: A 10-year experience in controlled trials. [2017]

7. Germany pubmed.ncbi.nlm.nih.gov

As soon as possible in IgE-cow's milk allergy immunotherapy. [2021]