Food AllergyPhase 2LoMONCT03799328
Low Dose Multi-OIT for Food Allergy (LoMo)
A Phase 2 study testing multi-OIT in people with Food Allergy, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 15 years
- Conditions the study is for
- Food Allergy
- What is being tested?
- multi-OIT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- 23 May 2019to 1 Apr 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Low Dose Multi Allergen Oral Immunotherapy for Food Allergy
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
Read the 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
- Being tested
- multi-OIT
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi-OITOther
low dose OIT to multiple foods
| Study group | Role | What they receive |
|---|---|---|
| multi-OIT | Experimental | Low dose OIT with multiple allergens Receives: Other: multi-OIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: month 0, month 18
Immunological change in IgG4
Change in allergen specific immunoglobulin G4 (IgG4) from baseline to end
Measured: month 0, month 18
Secondary outcomes (4)
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
Measured: month 0, month 18
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
Measured: pre-study, month 18
Desensitization to allergic food as assessed by maximum tolerated dose
Did they reach 300mg (cumulative) on the 18 month exit oral food challenge
Measured: month 18
Desensitization to allergic food as assessed by maximum tolerated dose
Did they reach 140mg (cumulative) on the 18 month exit oral food challenge
Measured: month 0, month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start23 May 2019
- Primary completion1 Nov 2022
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julia Upton, The Hospital for Sick Children
- Investigators
- Julia Upton, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799328
- Sponsor's protocol ID
- 1000060633
- Acronym
- LoMO
- Status last verified
- May 2025
- First submitted
- 20 Nov 2018
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Multi Allergen Oral Immunotherapy for Food Allergy
- ClinicalTrials.gov ID
- NCT03799328
- Acronym / sponsor ID
- LoMO / 1000060633
- Conditions
- Food Allergy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 23 May 2019 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 10 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| multi-OIT | Experimental | Other: multi-OITLow dose OIT with multiple allergens |
Who may qualify
- Ages
- 6 months to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multi-OITlow dose OIT to multiple foods | Other | multi-OIT |
Primary outcome
Desensitization to allergic food as assessed by change in maximum tolerated dose in a dichotomous manner
Time frame: month 0, month 18
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
Time frame: month 0, month 18
Change in allergen specific immunoglobulin G4 (IgG4) from baseline to end
4 secondary outcomes
Desensitization to allergic food as assessed by change in maximum tolerated dose on a linear scale
Time frame: month 0, month 18
Immunological change in IgG4
Time frame: pre-study, month 18
Desensitization to allergic food as assessed by maximum tolerated dose
Time frame: month 18
Desensitization to allergic food as assessed by maximum tolerated dose
Time frame: month 0, month 18
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Upton principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing multi-OIT in people with Food Allergy, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Desensitization to allergic food as assessed by change in maximum tolerated dose in a dichotomous manner (time frame: month 0, month 18). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.