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Milk Desensitization in Children

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ClinicalTrials.gov Identifier: NCT03644381
Recruitment Status : Recruiting
First Posted : August 23, 2018
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Bruce Mazer, McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary:
This study will assess a novel and potentially life-changing therapy, by actively treating Cow's Milk Allergy (CMA) using Oral Immunotherapy, which may allow patients to safely consume milk and other dairy products.

Condition or disease Intervention/treatment Phase
Cow Milk Allergy Other: Oral Immunotherapy Not Applicable

Detailed Description:
This is a randomized control study with a cross-over design. Eighty four boys and girls with between 6 to 20 years of age, diagnosed with IgE-mediated cow's milk allergy using strict skin testing and serological criteria, will be recruited for this study. 42 will undergo oral immunotherapy, while 42 will be followed as natural history controls but will be offered similar therapy, should it be successful, at the completion of one year. OIT subjects will initaiate therapy with a 2-day rush desensitization treatment using oral doses of milk, in the investigator's Clinical Investigation Unit. They will then continue the highest tolerated dose of milk at home for two weeks. Subsequently, they will return for weekly increases in doses until a maximum of 200 ml of milk is ingested daily. The primary clinical outcome will be a comparison of the amount of milk consumed safely on oral challenge performed prior to OIT, when the OIT dose has reached its maximum (200 ml or highest tolerated dose) and after one year of therapy. Patients will also be followed with clinical symptom scores and adverse event diarie. Their immunological parameters such as changes in milk-specific IgE, blocking antibodies (IgG4 and IgA) and regulatory T and B cells will also be monitored. It is expected that there will be important improvement in the ability to safely ingest milk and other dairy products, and this will be accompanied by significant decreases in IgE and increases in Regulatory T and B cells.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Milk Desensitization and Induction of Tolerance in Children
Actual Study Start Date : July 3, 2013
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Arm Intervention/treatment
No Intervention: Control
Following randomization, this arm will receive no intervention. After twelve months, participants in this group will undergo a singe-blind, placebo-controlled oral food challenge
Experimental: Treatment
Following randomization, participants in this group will receive escalating doses milk, up to a daily dose of 200 ml. Once they attain that dose, they will maintain it for one month. At the end of this period, they will undergo a open challenge to 300 ml of milk. They will then enter a year-long follow-up period
Other: Oral Immunotherapy
Starting from a very low level and over a period of several months, participants in the treatment group receive escalating doses of milk. Participants will also have blood and saliva draws to assess parameters of their immune system as well as skin prick testing




Primary Outcome Measures :
  1. Presence or absence of allergic symptoms during an oral challenge to milk [ Time Frame: 12 months ]
    Comparison of participants randomized to treatments arms who achieve milk desensitization compared to participants randomized to the control groups. This is measured by whether a participant is able to tolerate a total dose of 300 ml of milk during an oral food challenge


Secondary Outcome Measures :
  1. Change from baseline over the immunotherapy process of milk specigic IgE levels [ Time Frame: 18 months ]
    Measurement of milk specigic IgE before, during and after the desensitization process

  2. Change from baseline over the immunotherapy process of milk specigic IgA levels [ Time Frame: 18 months ]
    Measurement of milk specigic IgA before, during and after the desensitization process

  3. Change from baseline over the immunotherapy process of milk specigic IgG4 levels [ Time Frame: 18 months ]
    Measurement of milk specigic IgG4 before, during and after the desensitization process

  4. Change from baseline over the immunotherapy process of milk specigic IgE glycosylation levels [ Time Frame: 18 months ]
    Measurement of milk specigic IgE glycosylation before, during and after the desensitization process

  5. Change from baseline over the immunotherapy process of mast cell activation as measured by CD63 expression [ Time Frame: 18 months ]
    Measurement of mast cell activation as measured by CD63 expression before, during and after the desensitization process

  6. Change from baseline over the immunotherapy process of of DNA methylation levels [ Time Frame: 18 months ]
    Measurement of DNA methylation levels before, during and after the desensitization proces

  7. Change from baseline over the immunotherapy process of Regulatory T cell levels [ Time Frame: 18 months ]
    Measurement of Regulatory T cell levels, before, during and after the desensitization process



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Ages Eligible for Study:   6 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A history suggestive of IgE-mediated allergy to milk. An IgE-mediated reaction to a specific food is defined as a minimum of 2 mild symptoms and/or 1 moderate and/or 1 severe symptom that began within 1-20 minutes after ingestion or contact. Mild IgE-mediated symptoms include: pruritus, urticaria, flushing, or rhinoconjunctivitis. Moderate symptoms include angioedema (of face or lips), throat tightness, gastrointestinal complaints (vomiting, cramping, pain and/or diarrhea), or airway involvement (cough, nasal blockage, mucous ); severe symptoms include bronchospasm, wheezing, hypoxia, cyanosis, low blood pressure, or circulatory collapse (shock) (appendix A ,table 1) (61).
  2. The presence of at least one of the following confirmatory tests:

    • (a) Positive skin prick test to milk (weal diameter 3 mm larger than that of the normal saline control). The allergen used will be commercially available milk extracts (Omega Labs, Montreal, QC). Skin tests will traced in ink, tape transferred to paper and wheal diameter measured by computer assisted planometry.
    • (b) Detection of serum specific IgE (>0.35 kU/L) to milk or any of its proteins, measured by fluorescence enzyme immunoassay (Immunocap, Phadia, Uppsala, Sweden). The range for Immuncap is 0.35 - 100 and changes over time can be monitored effectively.
  3. Informed consent form signed by the parents or legal guardian

Exclusion Criteria:

  1. Patients with uncontrolled asthma or other uncontrolled respiratory diseases .
  2. Malignancies, autoimmune diseases and/or severe primary or secondary immune deficiencies.
  3. Patients receiving immunosuppressive therapy.
  4. Patients receiving β-blockers (including topical formulations).
  5. Associated diseases contraindicating the use of epinephrine: cardiovascular disease or severe hypertension.

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): NCT03644381


Contacts
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Contact: Duncan Lejtenyi, M.Sc 514-934-1934 ext 22369 duncan.lejtenyi@muhc.mcgill.ca
Contact: Jennifer Lee 514-934-1934 ext 67096 jennifer.lee@muhc.mcgill.ca

Locations
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Canada, Quebec
MUHC Recruiting
Montreal, Quebec, Canada, H4A3J1
Contact: Duncan Lejtenyi, MSc    514-934-1934 ext 22369    duncan.lejtenyi@muhc.mcgill.ca   
Contact: Jennifer Lee    514-934-1934 ext 67096    jennifer.lee@muhc.mcgill.ca   
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
  Study Documents (Full-Text)

Documents provided by Bruce Mazer, McGill University Health Centre/Research Institute of the McGill University Health Centre:
Informed Consent Form  [PDF] July 20, 2018


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Responsible Party: Bruce Mazer, Executive Director and CSO (Interim), McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT03644381    
Other Study ID Numbers: MP-CUSM-12-090-PED
First Posted: August 23, 2018    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018
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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Milk Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases