NCT03799328

Low Dose Multi-OIT for Food Allergy (LoMo)

Low Dose Multi Allergen Oral Immunotherapy for Food Allergy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 6 Months – 15 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a single-arm, open label, study of the intervention of low dose multiple-nut OIT in nut allergic children. After meeting eligibility criteria, participants will have a food challenge to 2-5 nuts. If the oral food challenge is positive, participants will be enrolled in the study to multiple nut OIT. A blood draw and quality of life (QOL) survey will occur at baseline. Participants will have dose escalation visits of the multiple nut OIT every 2 months to a target dose of 30mg of each nut protein. A blood draw and QOL survey will occur at 6 months. Participants will then continue with daily ingestion of the 30mg of each nut protein for 1 year with visits every 3 months. After 18 months from the start of the study, another oral food challenge will be given to participants to assess the change in the maximum tolerated dose of nuts. A blood draw will assess changes in the immune parameters. A QOL survey will occur at 18 months to assess changes in QOL.

Conditions

• Food Allergy

Interventions

Type	Name	Description
OTHER	multi-OIT	low dose OIT to multiple foods

Timeline

• Start date: 2019-05-23
• Primary completion: 2022-11-01
• Completion: 2025-04-01
• First posted: 2019-01-10
• Last updated: 2025-05-21

Locations

1 site across 1 country: Canada