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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for Cow's Milk Allergy (CMA) using Oral Immunotherapy. The goal is to help those allergic to milk safely consume dairy products by gradually introducing small doses of milk. Participants are divided into two groups: one receiving the treatment and another not receiving any intervention for comparison. This trial may suit individuals who have experienced allergic reactions, such as skin rashes or breathing difficulties, shortly after consuming milk. As an unphased trial, participants can contribute to groundbreaking research that could lead to new treatment options for CMA.

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).

Is there any evidence suggesting that oral immunotherapy for milk allergy is likely to be safe?

A previous study found that oral immunotherapy (OIT) for cow's milk allergy helped people gradually become more tolerant to milk. Many participants experienced mild side effects, such as itching or an upset stomach, but these were usually not serious enough to stop the treatment.

Another analysis showed that OIT could lessen milk allergy symptoms in children, although some children might have allergic reactions during the treatment.

Overall, research suggests that while OIT can improve milk tolerance, mild reactions are common. It's important to weigh these possible reactions against the benefits. The treatment aims to allow safe milk consumption in the long run. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for milk allergy, which often involve strict avoidance of milk and carrying emergency medications like antihistamines or epinephrine, oral immunotherapy (OIT) works by gradually desensitizing the immune system. By administering slowly increasing doses of milk, OIT aims to build tolerance over time, potentially allowing individuals to consume milk without triggering severe allergic reactions. Researchers are excited about OIT because it offers the possibility of actively modifying the immune response, rather than just managing symptoms, and could lead to a significant improvement in the quality of life for those with milk allergies.

What evidence suggests that Oral Immunotherapy might be an effective treatment for Cow's Milk Allergy?

Research has shown that oral immunotherapy, which participants in this trial may receive, can help people with cow's milk allergy become less sensitive to milk. In one study, 60% of participants who were very allergic to milk could drink a full glass of milk after treatment. A review of several studies found that this treatment can help children gradually tolerate milk better. However, some studies indicate that the benefits might decrease over time, so ongoing treatment may be needed to maintain desensitization. Overall, oral immunotherapy appears promising for making life safer and more comfortable for those with milk allergies. ^{1 2 6 7 8}

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39782691/

Clinical and immunological outcomes after randomized ... The aim of this study was to determine whether baked milk OIT (BMOIT) could reduce adverse reactions while still inducing desensitization.

2. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2025.1570050/full

Oral immunotherapy for cow's milk allergy in children This meta-analysis suggests that oral immunotherapy can effectively desensitize milk proteins in children with cow protein milk allergy, though ...

3. allergyandasthmacare.com allergyandasthmacare.com/oral-desensitization-for-milk-allergy-loses-effectiveness-over-time/

Oral desensitization for milk allergy loses effectiveness over time In the earlier presentation, researchers found oral immunotherapy allowed nine of 15 (60%) of severely milk-allergic participants to drink an 8 oz glass of milk ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12175089/

Oral immunotherapy for cow's milk allergy in children This meta-analysis suggests that oral immunotherapy can effectively desensitize milk proteins in children with cow protein milk allergy, though ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S277282932400081X

Long-term efficacy and safety of cow's milk anaphylaxis ... The mean duration of dairy immunotherapy was 21 months (639.2 days). The mean measured period of weekly allergen unresponsiveness was 12.6 months (383.2 days).

6. sciencedirect.com sciencedirect.com/science/article/pii/S2213219823012023

Long-term clinical outcome of oral immunotherapy in adults ... Oral immunotherapy increases tolerance to food allergies in the long term. Mild adverse events are common; however, social reasons usually lead to ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11250201/

A review of the safety of oral immunotherapy in clinical trial ... Reviewing safety across OIT studies broadly is a difficult task because foods have unique allergenic characteristics and patients have unique immune responses.

8. jaci-global.org jaci-global.org/article/S2772-8293(24)00081-X/fulltext

Long-term efficacy and safety of cow's milk anaphylaxis ... The concept of allergen unresponsiveness in milk oral immunotherapy has been reported. Reported outcomes were based on small patient surveys.