Milk Desensitization in Children

NCT03644381 | Unknown

• 1 other identifier: MP-CUSM-12-090-PED
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Cow Milk Allergy

Outcome Measures

Primary Outcomes (1)

• Presence or absence of allergic symptoms during an oral challenge to milk

  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

  12 months

Secondary Outcomes (7)

• Change from baseline over the immunotherapy process of milk specigic IgE levels

  18 months

• Change from baseline over the immunotherapy process of milk specigic IgA levels

  18 months

• Change from baseline over the immunotherapy process of milk specigic IgG4 levels

  18 months

• Change from baseline over the immunotherapy process of milk specigic IgE glycosylation levels

  18 months

• Change from baseline over the immunotherapy process of mast cell activation as measured by CD63 expression

  18 months

Study Arms (2)

Control

NO INTERVENTION

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

Treatment

EXPERIMENTAL

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

Interventions

Oral Immunotherapy OTHER

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

Treatment

Eligibility Criteria

• Age: 6 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).
• 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.
• Informed consent form signed by the parents or legal guardian

You may not qualify if:

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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

MUHC

Montreal, Quebec, H4A3J1, Canada

Location

MeSH Terms

Conditions

Milk Hypersensitivity

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Director and CSO (Interim)

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: August 23, 2018
• Study Start: July 3, 2013
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)