Low Dose Multi-OIT for Food Allergy (LoMo)

NCT03799328 | Completed Phase 2

• 1 other identifier: 1000060633
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Oral immunotherapy (OIT) is a food allergy treatment where small amounts of the food a child is allergic to is eaten and gradually increased over time with the aim to be able to eat a certain amount of the allergen without experiencing an allergic reaction. While this process works in many children there are concerns about safety, feasibility and drop-outs and how to adapt protocols for multiple allergies. Many OIT trials have targeted approximately 4000mg of single food/day. In these trials up to 40% drop-out. There is evidence much lower doses can have beneficial effects. The investigators will evaluate if low doses of foods can allow for OIT to multiple foods. This approach may have efficacy against accidental exposure and be able to demonstrate immune changes. This approach may have a low burden of treatment and a low rate of allergic reactions and

Conditions

Food Allergy

Outcome Measures

Primary Outcomes (2)

• Desensitization to allergic food as assessed by change in maximum tolerated dose in a dichotomous manner

  Change in how much nuts the participant can eat without an allergic reaction after the low dose OIT assessed as dichotomous did the participant reach 5 times the baseline eliciting dose

  month 0, month 18

• Immunological change in IgG4

  Change in allergen specific immunoglobulin G4 (IgG4) from baseline to end

  month 0, month 18

Secondary Outcomes (4)

• Desensitization to allergic food as assessed by change in maximum tolerated dose on a linear scale

  month 0, month 18

• Immunological change in IgG4

  pre-study, month 18

• Desensitization to allergic food as assessed by maximum tolerated dose

  month 18

• Desensitization to allergic food as assessed by maximum tolerated dose

  month 0, month 18

Other Outcomes (9)

• Feasibility analysis as assessed by can the patients achieve the maintenance dosing of the allergen mix for OIT

  month 18

• Feasibility analysis as assessed by drop-out rate

  month 18

• Incidence of Treatment-Emergent Adverse Events: Safety analysis as assessed by use of epinephrine

  month 18

Study Arms (1)

multi-OIT

EXPERIMENTAL

Low dose OIT with multiple allergens

Other: multi-OIT

Interventions

multi-OIT OTHER

low dose OIT to multiple foods

multi-OIT

Eligibility Criteria

• Age: 6 Months - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Relevant allergy to 2-5 nuts
• Serum immunoglobulin E (IgE) \>0.35 kilounits/L (kU/L) (determined by UniCAP within the past 12 months) and/or a SPT to nut \>3 mm compared to control
• Positive oral food challenge (OFC) to less than 300mg of a nut in the nut mix at baseline (cumulative 444mg).

You may not qualify if:

• History of frequent or repeated, severe or life-threatening episodes of anaphylactic shock
• use of omalizumab or other non-traditional forms of allergen immunomodulatory therapy (not including corticosteroids) or biologic therapy in the 12 months prior to study entry
• history of eosinophilic gastrointestinal disease, uncontrolled asthma as defined by Global Initiative for Asthma (GINA)
• use of beta-blockers(oral)
• use of angiotensin-converting enzyme inhibitors (ACE)
• fails to tolerate 4mg of peanut after the first desensitization day
• Other significant medical conditions that in the opinion of the investigator prevent participation in the study,
• Previous intubation due to allergies or asthma,
• Symptomatic atopic dermatitis or chronic urticaria which may interfere with ability to evaluate oral immunotherapy and /or requiring daily medication including antihistamines,
• Patients with problems related to compliance or following study instructions, Inability to come to hospital every for dose escalation
• Pregnancy
• Non-fluency in English because participants may need to communicate with us after hours and be able to describe symptoms and concerns and follow instructions to treat anaphylaxis

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Julia Upton

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: January 10, 2019
• Study Start: May 23, 2019
• Primary Completion: November 1, 2022
• Study Completion: April 1, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)