Oral Immunotherapy for Peanut and Tree Nut Allergy

Recruiting at 1 trial location

Overseen By Duncan Lejtenyi, MSc

Age: < 65

Sex: Any

Trial Phase: Academic

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

Must not be taking: Immunosuppressors, β-blockers

Disqualifiers: Respiratory instability, Cardiovascular disease, others

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

Compensation: Varies

Number of Visits: 1

Duration: 6 months

51 Participants Needed

Trial Summary

What is the purpose of this trial?

this study evaluates whether tolerance to peanuts and tree nuts can be induced in patients through a process of oral immunotherapy. Participants will be randomized into groups receiving oral immunotherapy and a control group that will receive no intervention

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on immunosuppressor therapy or β-blockers. If you are taking these, you would need to stop them to join the trial.

What data supports the effectiveness of the treatment Oral immunotherapy for peanut and tree nut allergy?

Research shows that oral immunotherapy can effectively increase the threshold of reactivity to peanuts, helping to protect against accidental ingestion. Although some adverse reactions occur, most patients continue treatment and report improved quality of life. ^{1 2 3 4 5}

Is oral immunotherapy for peanut and tree nut allergy safe?

Research shows that oral immunotherapy for peanut allergy is generally safe, with most reactions being mild. However, there can be moderate reactions, and in rare cases, treatment may require medication like epinephrine (a medicine used to treat severe allergic reactions). ^{1 5 6 7 8}

How is oral immunotherapy for peanut and tree nut allergy different from other treatments?

Oral immunotherapy for peanut and tree nut allergies is unique because it involves gradually consuming small amounts of the allergen to build up tolerance, unlike other treatments that focus on avoiding the allergen. This method aims to desensitize the immune system, but it can have significant side effects, such as allergic reactions, which limits its widespread use. ^{1 5 9 10 11}

Eligibility Criteria

This trial is for individuals aged 2-40 with a history of immediate allergic reactions to peanuts or tree nuts, confirmed by skin tests and specific IgE blood tests. They must have had a reaction within 120 minutes of exposure and consent from parents/guardians if underage. It excludes those with unstable respiratory conditions, immune diseases, severe hypertension, on immunosuppressors or β-blockers.

Inclusion Criteria

Patients between 2 and 40 years of age who satisfy all the following criteria will be included:

A history suggestive of immediate allergy to peanut/tree nut. A convincing clinical history of an IgE mediated reaction to a specific food will be defined as a minimum of 2 mild signs/symptoms or 1 moderate or 1 severe sign/symptom that was likely IgE mediated and occurred within 120 minutes after ingestion or contact (or inhalation in the case of fish and shellfish). Reactions will be considered mild if they involve pruritus, urticaria, flushing, or rhinoconjunctivitis; moderate if they involve angioedema, throat tightness, gastrointestinal complaints, or breathing difficulties (other than wheeze); and severe if they involve wheeze, cyanosis, or circulatory collapse. The presence of at least one of the following confirmatory tests:

Positive SPT to peanut/tree nut or its proteins (weal diameter 3 mm larger than that of the normal saline control). The allergens used will be commercial extracts of peanut/tree nut (Omega Labs, Toronto, Ontario).

Exclusion Criteria

You have breathing problems that are not under control or stable.

You have a serious form of cancer or immune system disease.

Patients receiving immunosuppressor therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive escalating doses of the appropriate allergen, up to a dose of 30 mg or 300 mg, followed by a maintenance period of six months

6 months

Regular visits for dose escalation and monitoring

Follow-up

Participants undergo a single-blind, placebo-controlled oral food challenge to assess desensitization

1 month

1 visit (in-person)

Long-term Monitoring

Participants are monitored for changes in immunological markers such as IgG4, IgA, IgE, and DNA methylation levels

21 months

Treatment Details

Interventions

• Oral immunotherapy

Trial Overview The study is testing oral immunotherapy's ability to induce tolerance in patients allergic to peanuts and tree nuts. Participants are randomly divided into two groups: one receiving the therapy and another serving as a control group without any intervention.

Participant Groups

Group I: 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

Group II: Low-dose Active Control 1 Intervention

Following randomization, participants in this group will receive escalating doses of the appropriate allergen, up to a dose of 30 mg. Once they attain that dose, they will maintain it for six months. At the end of this maintenance period, they will undergo a singe-blind, placebo-controlled oral food challenge

Group III: High-dose Active Control 1 Intervention

Following randomization, participants in this group will receive escalating doses of the appropriate allergen, up to a dose of 300 mg. Once they attain that dose, they will maintain it for six months. At the end of this maintenance period, they 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+

Julia Upton, Hospital for Sick Children, University of Toronto

Collaborator

Trials

1

Recruited

50+

Findings from Research

Oral immunotherapy (OIT) has been shown to effectively increase the threshold of reactivity to peanuts and other food allergens, improving patients' quality of life, as evidenced by numerous studies and meta-analyses.

While OIT can cause common adverse events during treatment, serious reactions are rare, and most patients are willing to continue treatment due to the potential benefits of protection against accidental allergen exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral immunotherapy for peanut allergy: The pro argument. Chinthrajah, RS., Cao, S., Dunham, T., et al.[2020]

In a real-world study involving 270 preschool children undergoing peanut oral immunotherapy (P-OIT), 90% successfully reached the maintenance dose, indicating high treatment adherence and efficacy.

The majority of reactions during treatment were mild, with only 4.1% of patients requiring epinephrine, suggesting that P-OIT is generally safe, although there is a small risk of severe reactions in some individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First Real-World Safety Analysis of Preschool Peanut Oral Immunotherapy. Soller, L., Abrams, EM., Carr, S., et al.[2020]

Gamma irradiation of walnut, cashew, hazelnut, and almond flours significantly reduces harmful microbial contamination without affecting total protein or allergen content, making these flours suitable for oral immunotherapy (OIT) trials.

The processed tree nut flours maintain stable microbial levels, protein, and allergen content over a 24-month period, ensuring they meet FDA standards for safety and efficacy in OIT drug products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Irradiated Tree Nut Flours for Use in Oral Immunotherapy. Penumarti, A., Szczepanski, N., Kesselring, J., et al.[2021]

References

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

Oral immunotherapy for peanut allergy (PACE): a systematic review and meta-analysis of efficacy and safety. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Long-term outcome of peanut oral immunotherapy-Real-life experience. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Assessing the efficacy of oral immunotherapy for the desensitisation of peanut allergy in children (STOP II): a phase 2 randomised controlled trial: a critical appraisal. [2022]

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

Oral immunotherapy for peanut allergy: The pro argument. [2020]

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

Community Private Practice Clinical Experience with Peanut Oral Immunotherapy. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Oral Immunotherapy in Japanese Children with Anaphylactic Peanut Allergy. [2022]

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

Safety of a peanut oral immunotherapy protocol in children with peanut allergy. [2022]

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

First Real-World Safety Analysis of Preschool Peanut Oral Immunotherapy. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Peanut gastrointestinal delivery oral immunotherapy in adolescents: Results of the build-up phase of a randomized, double-blind, placebo-controlled trial (PITA study). [2019]

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

Irradiated Tree Nut Flours for Use in Oral Immunotherapy. [2021]

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

Efficacy and Safety of AR101 in Oral Immunotherapy for Peanut Allergy: Results of ARC001, a Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial. [2023]