Low-Dose Multi-Oral Immunotherapy for Food Allergies

(LoMO Trial)

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: The Hospital for Sick Children

Must not be taking: Omalizumab, Beta-blockers, ACE inhibitors

Disqualifiers: Severe anaphylaxis, Uncontrolled asthma, Pregnancy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 10

18 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if giving nut-allergic children very small amounts of multiple nuts can help them tolerate these nuts without allergic reactions. The goal is to make their immune system get used to the nuts over time.

Research Team

Julia Upton

Principal Investigator

The Hospital for Sick Children

Eligibility Criteria

This trial is for children with allergies to 2-5 types of nuts, confirmed by blood tests or skin prick tests, and a positive food challenge. They must not be pregnant, on certain allergy or asthma medications in the past year, have specific gastrointestinal diseases, uncontrolled asthma, severe anaphylaxis history, non-fluency in English, compliance issues or inability to attend regular hospital visits.

Inclusion Criteria

I had a reaction to a small amount of nuts in a test.

My allergy test shows I'm sensitive to nuts or my IgE levels are above 0.35 kU/L.

Relevant allergy to 2-5 nuts

Exclusion Criteria

fails to tolerate 4mg of peanut after the first desensitization day

You have a history of severe and life-threatening episodes of anaphylactic shock happening repeatedly.

I have a history of eosinophilic gastrointestinal disease or uncontrolled asthma.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo a food challenge to 2-5 nuts, blood draw, and quality of life survey

1 day

1 visit (in-person)

Dose Escalation

Participants have dose escalation visits every 2 months to reach a target dose of 30mg of each nut protein

6 months

3 visits (in-person)

Maintenance

Participants continue daily ingestion of 30mg of each nut protein with visits every 3 months

12 months

4 visits (in-person)

Follow-up

Participants undergo an oral food challenge, blood draw, and quality of life survey to assess changes

1 day

1 visit (in-person)

Treatment Details

Interventions

• Multi-OIT

Trial Overview The LoMo trial is testing whether low doses of multiple allergens can help children with nut allergies without causing significant reactions. It aims to see if this approach is safer and more feasible than current high-dose single-allergen OIT treatments that often lead to drop-outs.

Participant Groups

Group I: multi-OIT Experimental Treatment 1 Intervention

Low dose OIT with multiple allergens

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+