Clinical trial NCT03799328: Low Dose Multi-OIT for Food Allergy (LoMo)
Official title: Low Dose Multi Allergen Oral Immunotherapy for Food Allergy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Food Allergy
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2019-01-10
Enrollment: 18
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Desensitization to allergic food as assessed by change in maximum tolerated dose in a dichotomous manner
timeFrame: month 0, month 18
measure: Immunological change in IgG4
timeFrame: month 0, month 18
Secondary outcomes:
measure: Desensitization to allergic food as assessed by change in maximum tolerated dose on a linear scale
timeFrame: month 0, month 18
measure: Immunological change in IgG4
timeFrame: pre-study, month 18
measure: Desensitization to allergic food as assessed by maximum tolerated dose
timeFrame: month 18
measure: Desensitization to allergic food as assessed by maximum tolerated dose
timeFrame: month 0, month 18
Other outcomes:
measure: Feasibility analysis as assessed by can the patients achieve the maintenance dosing of the allergen mix for OIT
timeFrame: month 18
measure: Feasibility analysis as assessed by drop-out rate
timeFrame: month 18
measure: Incidence of Treatment-Emergent Adverse Events: Safety analysis as assessed by use of epinephrine
timeFrame: month 18
measure: Quality of life scale
timeFrame: month 0, month 18
measure: Change in allergen specific IgE, and components
timeFrame: month 0, month 18
measure: Basophil activation test
timeFrame: month 0, month 18
measure: Skin prick test (SPT) reactivity to the individual nut extracts
timeFrame: month 0, month 18
measure: High content functional immune profiling via mass cytometry and single cell sorting
timeFrame: pre-study, month 18
measure: Number of participants with treatment related adverse effects
timeFrame: month 0, month 18
Locations:
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Julia Upton
role: PRINCIPAL_INVESTIGATOR
References: