Clinical Trials

Low Dose Multi-OIT for Food Allergy (LoMo)

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	6 Months - 15 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03799328
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	The Hospital for Sick Children
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Julia Upton
Principal Investigator Affiliation	The Hospital for Sick Children
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	Canada
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Food Allergy

Additional Details

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.

Arms & Interventions

Arms

Experimental: multi-OIT

Low dose OIT with multiple allergens

Interventions

Other: - multi-OIT

low dose OIT to multiple foods

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hospital for Sick Children, Toronto, Ontario, Canada

Status

Address

Hospital for Sick Children

Toronto, Ontario, M5G1X8

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