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Trial record 6 of 340 for:    "Food Allergy"

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

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ClinicalTrials.gov Identifier: NCT03799328
Recruitment Status : Recruiting
First Posted : January 10, 2019
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Julia Upton, The Hospital for Sick Children

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


Condition or disease Intervention/treatment Phase
Food Allergy Other: multi-OIT Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Low Dose Multi Allergen Oral Immunotherapy for Food Allergy
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: multi-OIT
Low dose OIT with multiple allergens
Other: multi-OIT
low dose OIT to multiple foods




Primary Outcome Measures :
  1. 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

  2. Immunological change in IgG4 [ Time Frame: month 0, month 18 ]
    Change in allergen specific immunoglobulin G4 (IgG4) from baseline to end


Secondary Outcome Measures :
  1. Desensitization to allergic food as assessed by change in maximum tolerated dose on a linear scale [ Time Frame: month 0, month 18 ]
    A continuous variable amount tolerated at baseline vs at end

  2. Immunological change in IgG4 [ Time Frame: pre-study, month 18 ]
    Change in IgG4 from measures from historical data to 18 month of study. Some patients will have historical IgG4 values to compare

  3. Desensitization to allergic food as assessed by maximum tolerated dose [ Time Frame: month 18 ]
    Did they reach 300mg (cumulative) on the 18 month exit oral food challenge

  4. Desensitization to allergic food as assessed by maximum tolerated dose [ Time Frame: month 0, month 18 ]
    Did they reach 140mg (cumulative) on the 18 month exit oral food challenge


Other Outcome Measures:
  1. Feasibility analysis as assessed by can the patients achieve the maintenance dosing of the allergen mix for OIT [ Time Frame: month 18 ]
    Proportion who achieve maintenance doses of their allergen mix (descriptive)

  2. Feasibility analysis as assessed by drop-out rate [ Time Frame: month 18 ]
    Proportion who drop-out of the study (descriptive)

  3. Incidence of Treatment-Emergent Adverse Events: Safety analysis as assessed by use of epinephrine [ Time Frame: month 18 ]
    Administration of epinephrine; (descriptive);

  4. Quality of life scale [ Time Frame: month 0, month 18 ]
    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.

  5. Change in allergen specific IgE, and components [ Time Frame: month 0, month 18 ]
    Change in allergen specific IgE, and components via microarray

  6. Basophil activation test [ Time Frame: month 0, month 18 ]
    Basophil activation test

  7. Skin prick test (SPT) reactivity to the individual nut extracts [ Time Frame: month 0, month 18 ]
    The size of the skin prick test will be compared

  8. High content functional immune profiling via mass cytometry and single cell sorting [ Time Frame: pre-study, month 18 ]
    Compare the change in the immune pattern

  9. Number of participants with treatment related adverse effects [ Time Frame: month 0, month 18 ]
    Diaries will be analyzed for allergic symptoms and tabulated



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Months to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03799328


Contacts
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Contact: Julia Upton, MD, MPH 4168138627 julia.upton@sickkids.ca
Contact: Thomas Eiwegger, MD 4168138626 thomas.eiwegger@sickkids.ca

Locations
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Canada, Ontario
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G1X8
Contact: Julia Upton, MD, MPH    4168138634    julia.upton@sickkids.ca   
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Julia Upton The Hospital for Sick Children
  Study Documents (Full-Text)

Documents provided by Julia Upton, The Hospital for Sick Children:

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Responsible Party: Julia Upton, Principal Investigator, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT03799328     History of Changes
Other Study ID Numbers: 1000060633
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate