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Low Dose Multi-OIT for Food Allergy (LoMo) (LoMO)

Primary Purpose

Food Allergy

Status

Active

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

multi-OIT

About this trial

This is an interventional treatment trial for Food Allergy

Eligibility Criteria

6 Months - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).

Exclusion Criteria:

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

Sites / Locations

Hospital for Sick Children

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

multi-OIT

Arm Description

Low dose OIT with multiple allergens

Outcomes

Primary Outcome Measures

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

Immunological change in IgG4

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

Secondary Outcome Measures

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

A continuous variable amount tolerated at baseline vs at end

Immunological change in IgG4

Change in IgG4 from measures from historical data to 18 month of study. Some patients will have historical IgG4 values to compare

Desensitization to allergic food as assessed by maximum tolerated dose

Did they reach 300mg (cumulative) on the 18 month exit oral food challenge

Desensitization to allergic food as assessed by maximum tolerated dose

Did they reach 140mg (cumulative) on the 18 month exit oral food challenge

Full Information

NCT ID

NCT03799328

First Posted

November 20, 2018

Last Updated

May 4, 2022

Sponsor

The Hospital for Sick Children

1. Study Identification

Unique Protocol Identification Number

NCT03799328

Brief Title

Low Dose Multi-OIT for Food Allergy (LoMo)

Acronym

LoMO

Official Title

Low Dose Multi Allergen Oral Immunotherapy for Food Allergy

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 23, 2019 (Actual)

Primary Completion Date

January 2025 (Anticipated)

Study Completion Date

January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Hospital for Sick Children

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Food Allergy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

multi-OIT

Arm Type

Experimental

Arm Description

Low dose OIT with multiple allergens

Intervention Type

Other

Intervention Name(s)

multi-OIT

Intervention Description

low dose OIT to multiple foods

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

month 0, month 18

Title

Immunological change in IgG4

Description

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

Time Frame

month 0, month 18

Secondary Outcome Measure Information:

Title

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

Description

A continuous variable amount tolerated at baseline vs at end

Time Frame

month 0, month 18

Title

Immunological change in IgG4

Description

Change in IgG4 from measures from historical data to 18 month of study. Some patients will have historical IgG4 values to compare

Time Frame

pre-study, month 18

Title

Desensitization to allergic food as assessed by maximum tolerated dose

Description

Did they reach 300mg (cumulative) on the 18 month exit oral food challenge

Time Frame

month 18

Title

Desensitization to allergic food as assessed by maximum tolerated dose

Description

Did they reach 140mg (cumulative) on the 18 month exit oral food challenge

Time Frame

month 0, month 18

Other Pre-specified Outcome Measures:

Title

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

Description

Proportion who achieve maintenance doses of their allergen mix (descriptive)

Time Frame

month 18

Title

Feasibility analysis as assessed by drop-out rate

Description

Proportion who drop-out of the study (descriptive)

Time Frame

month 18

Title

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

Description

Administration of epinephrine; (descriptive);

Time Frame

month 18

Title

Quality of life scale

Description

Change in quality of life at 18m of children compared to baseline assessment (using validated questionnaire: Food allergy quality of life questionnaires (FAQLQ) FAQLQ Parental form (PF) for ages 0-12 OR the FAQLQ-teenager form (TF) using total score. The FAQLQ total and domain scores range from 1-7 with higher scores indicative of worse health related quality of life with the total score being the average of the domain scores. The domains include Emotional Impact, Social and Dietary Restrictions, Food Anxiety, Allergen Avoidance, and Risk of Accidental Exposure.

Time Frame

month 0, month 18

Title

Change in allergen specific IgE, and components

Description

Change in allergen specific IgE, and components via microarray

Time Frame

month 0, month 18

Title

Basophil activation test

Description

Basophil activation test

Time Frame

month 0, month 18

Title

Skin prick test (SPT) reactivity to the individual nut extracts

Description

The size of the skin prick test will be compared

Time Frame

month 0, month 18

Title

High content functional immune profiling via mass cytometry and single cell sorting

Description

Compare the change in the immune pattern

Time Frame

pre-study, month 18

Title

Number of participants with treatment related adverse effects

Description

Diaries will be analyzed for allergic symptoms and tabulated

Time Frame

month 0, month 18

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Julia Upton

Organizational Affiliation

The Hospital for Sick Children

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital for Sick Children

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G1X8

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

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Low Dose Multi-OIT for Food Allergy (LoMo)

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