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Immunotherapy
Low-Dose Multi-Oral Immunotherapy for Food Allergies (LoMO Trial)
Phase 2
Waitlist Available
Led By Julia Upton
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Positive oral food challenge (OFC) to less than 300mg of a nut in the nut mix at baseline (cumulative 444mg).
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 18
Awards & highlights
LoMO Trial Summary
This trial will test if a low-dose immunotherapy approach can help children with multiple food allergies.
Who is the study for?
This trial is for children with allergies to 2-5 types of nuts, confirmed by blood tests or skin prick tests, and a positive food challenge. They must not be pregnant, on certain allergy or asthma medications in the past year, have specific gastrointestinal diseases, uncontrolled asthma, severe anaphylaxis history, non-fluency in English, compliance issues or inability to attend regular hospital visits.Check my eligibility
What is being tested?
The LoMo trial is testing whether low doses of multiple allergens can help children with nut allergies without causing significant reactions. It aims to see if this approach is safer and more feasible than current high-dose single-allergen OIT treatments that often lead to drop-outs.See study design
What are the potential side effects?
Potential side effects may include allergic reactions ranging from mild symptoms like itching or hives to more serious conditions such as difficulty breathing. The lower dose approach seeks to minimize these risks compared to higher dose therapies.
LoMO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had a reaction to a small amount of nuts in a test.
Select...
My allergy test shows I'm sensitive to nuts or my IgE levels are above 0.35 kU/L.
LoMO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 18
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 18
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Desensitization to allergic food as assessed by change in maximum tolerated dose in a dichotomous manner
Secondary outcome measures
Desensitization to allergic food as assessed by change in maximum tolerated dose on a linear scale
Desensitization to allergic food as assessed by maximum tolerated dose
Immunological change in IgG4
Other outcome measures
Basophil activation test
Change in allergen specific IgE, and components
Feasibility analysis as assessed by can the patients achieve the maintenance dosing of the allergen mix for OIT
+6 moreLoMO Trial Design
1Treatment groups
Experimental Treatment
Group I: multi-OITExperimental Treatment1 Intervention
Low dose OIT with multiple allergens
Find a Location
Who is running the clinical trial?
The Hospital for Sick ChildrenLead Sponsor
686 Previous Clinical Trials
6,944,775 Total Patients Enrolled
1 Trials studying Food Allergy
121 Patients Enrolled for Food Allergy
Julia UptonPrincipal InvestigatorThe Hospital for Sick Children
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of severe and life-threatening episodes of anaphylactic shock happening repeatedly.I have a history of eosinophilic gastrointestinal disease or uncontrolled asthma.I am taking oral beta-blockers.I haven't used omalizumab or similar allergy treatments in the last year.You are pregnant.I have been intubated before due to allergies or asthma.I can follow the study's instructions and come to the hospital as needed.I had a reaction to a small amount of nuts in a test.You have other medical conditions that the doctor thinks might make it difficult for you to participate in the study.I am taking ACE inhibitors.I am fluent in English and can communicate my symptoms and follow emergency instructions.My allergy test shows I'm sensitive to nuts or my IgE levels are above 0.35 kU/L.You have skin conditions such as atopic dermatitis or chronic urticaria that cause symptoms and require daily medication, which may make it difficult to evaluate the oral immunotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: multi-OIT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA cleared multi-OIT for use?
"While Phase 2 trials are not as well established as those in later stages, there is still some data supporting the safety of multi-OIT."
Answered by AI
Are elderly patients welcome in this experiment?
"This clinical trial is only for children aged 6 months to 15 years old. Out of the 251 total trials, this one is specifically designed 86 other trials focus on patients under 18 and 165 target adults over 65."
Answered by AI
How can I become a part of this experiment?
"This study is for children aged 6 months to 15 years old who have food allergies. The team conducting the trial needs around 18 patients in total."
Answered by AI
Are we still looking for volunteers for this experiment?
"Unfortunately, this specific clinical trial is not currently enrolling patients. Although, there are many other similar trials that might be a good fit for you; as of right now, 271 studies are recruiting."
Answered by AI
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