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Immunotherapy
Oral Immunotherapy for Milk Allergy
N/A
Waitlist Available
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
Study Summary
This trial will test a new allergy treatment that may let patients eat milk and dairy products safely.
Who is the study for?
This trial is for children with a confirmed milk allergy, either through skin tests or blood tests showing specific antibodies to milk proteins. They must have had symptoms of an allergic reaction to milk. Parents or guardians need to consent for participation. Children can't join if they're on immunosuppressive drugs, have heart issues that make epinephrine use risky, uncontrolled asthma, are taking beta-blockers, or have cancer/autoimmune diseases.Check my eligibility
What is being tested?
The study is testing Oral Immunotherapy as a treatment for Cow's Milk Allergy (CMA). The goal is to see if this therapy allows children with CMA to safely consume dairy products without having allergic reactions.See study design
What are the potential side effects?
Possible side effects may include itching, hives, flushing, nasal congestion (mild); swelling of the face/lips, throat tightness, stomach pain/vomiting/diarrhea (moderate); and in severe cases wheezing or low blood pressure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Presence or absence of allergic symptoms during an oral challenge to milk
Secondary outcome measures
Change from baseline over the immunotherapy process of Regulatory T cell levels
Change from baseline over the immunotherapy process of mast cell activation as measured by CD63 expression
Change from baseline over the immunotherapy process of milk specigic IgA levels
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TreatmentExperimental Treatment1 Intervention
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
Group II: ControlActive Control1 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
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Who is running the clinical trial?
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
442 Previous Clinical Trials
159,090 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have heart disease or severe high blood pressure.I have no history of cancer, autoimmune diseases, or severe immune deficiencies.I am currently on medication that suppresses my immune system.I am currently taking β-blockers, including creams or ointments.My asthma or other lung condition is not under control.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Treatment
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.
Is participation in this trial open to me?
"This clinical trial is recruiting 84 participants with cow's milk allergy aged between 6 and 20 years."
Answered by AI
Does this clinical trial include patients below the age of twenty?
"For this medical trial, the ideal patient is aged between 6 and 20 years of age."
Answered by AI
Is this scientific trial open to enrolling new participants?
"The trail has been posted on clinicaltrials.gov, but is not actively seeking participants at this time. The trial was first introduced in July 2013 and last updated in July 2022; however, other trials are accepting patients right now instead of this one."
Answered by AI
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