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Immunotherapy
Baked Milk Therapy for Cow's Milk Allergy
Phase 2
Waitlist Available
Led By Robert Wood, MD
Research Sponsored by Johns Hopkins University
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 baseline, 1 year and 2 years
Awards & highlights
Study Summary
This trial is testing whether a treatment made from cow's milk is safe for people with cow's milk allergies.
Who is the study for?
This trial is for children and teens aged 3-18 with a confirmed cow's milk allergy, positive skin test, and specific IgE levels. They must have had symptoms from cow's milk and carry epinephrine. It excludes those with severe anaphylaxis history, chronic diseases needing therapy (except some), recent emergency visits for asthma, certain medication use within the last year, or participation in other food allergy studies.Check my eligibility
What is being tested?
The study tests if baked non-fat cow's milk powder can safely treat cow's milk allergy compared to a placebo (tapioca powder). Participants will be randomly assigned to receive either the baked milk treatment or placebo to evaluate effectiveness and safety.See study design
What are the potential side effects?
Potential side effects may include allergic reactions ranging from mild symptoms like rash or digestive disturbances to more serious ones such as difficulty breathing. The severity of side effects can vary among individuals.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1 year and 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 year and 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Secondary outcome measures
Change in Maximum Tolerated Dose of Baked Milk
Change in Milk Skin Prick Test Responses
Change in Milk-specific IgE Level
+4 moreSide effects data
From 2024 Phase 2 trial • 41 Patients • NCT03462030100%
Gastrointestinal symptoms
93%
Oropharyngeal symptoms
93%
Cutaneous symptoms
80%
Lower respiratory tract symptoms
100%
80%
60%
40%
20%
0%
Study treatment Arm
Baked Milk Immunotherapy
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Baked Milk ImmunotherapyExperimental Treatment1 Intervention
Subjects will receive baked milk oral immunotherapy with baked non-fat cow's milk powder as the intervention. Subjects will undergo an initial dose escalation, build-up, and then a maintenance period.
Group II: PlaceboPlacebo Group1 Intervention
Subjects will receive oral immunotherapy with the placebo control (tapioca powder). Subjects will undergo an initial dose escalation, build-up, and then a maintenance period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Baked non-fat cow's milk powder
2018
Completed Phase 2
~50
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,260 Previous Clinical Trials
14,820,739 Total Patients Enrolled
Myra Reinhardt FoundationUNKNOWN
La Jolla Institute for Allergy & ImmunologyOTHER
4 Previous Clinical Trials
3,335 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have taken medications that affect your immune system or biological therapies in the last year, except for corticosteroids.You have a long-term illness that needs ongoing treatment, like heart disease or diabetes.Your asthma is very serious or not well controlled, which means you may have frequent or severe symptoms.You have taken or plan to take an experimental drug within the past three months.You had a strong negative reaction during a test where you were given a food item in a controlled environment.You have experienced a severe allergic reaction that could be life-threatening.You have experienced a severe allergic reaction in the past that caused low blood pressure, problems with your nervous system, or required the use of a breathing machine.You have taken part in a study for treating food allergy in the last 6 months.You are currently in the early phase of allergy treatment. However, if you are already receiving maintenance allergy treatment and doing well, you can participate in the study.You have needed a breathing tube due to asthma in the past.Your atopic dermatitis is not well controlled.You cannot handle consuming at least 3 mg of baked milk protein on a specific day of the study.You are currently taking medications like omalizumab, mepolizumab, beta-blockers, ACE inhibitors, angiotensin-receptor blockers, calcium channel blockers, or tricyclic antidepressants.You have had a condition called eosinophilic esophagitis in the last 3 years.You have experienced allergic reactions to cow's milk, such as eczema, hives, breathing problems, stomach issues, rashes, or mouth discomfort.You are allergic to the ingredients in the placebo or have had an allergic reaction to a previous dose of placebo during the qualifying test.You must have an epinephrine auto-injector (a device that helps treat severe allergic reactions) with you at all times.
Research Study Groups:
This trial has the following groups:- Group 1: Baked Milk Immunotherapy
- Group 2: Placebo
Awards:
This trial has 0 awards, including: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.
Am I eligible to be a participant in this research?
"This clinical trial seeks 41 minors aged 3 to 18 with a history of hypersensitivity. Applicants should possess self-injectable epinephrine, accept any race or ethnicity, practice an effective contraceptive method if applicable, and have experienced positive reactions following ≤444 mg of baked milk powder in the initial qualifying double blind placebo-controlled food challenge."
Answered by AI
Has the Food and Drug Administration given their blessing to non-fat cow's milk powder that has been processed through baking?
"Given that the available evidence is limited to safety, Baked non-fat cow's milk powder received a score of 2."
Answered by AI
Is geriatric participation allowed in this experiment?
"This clinical trial is seeking applicants aged 3 to 18. Specifically, 85 studies are for minors and 156 trials pertain to seniors over the age of 65."
Answered by AI
What are the foremost aims of this experiment?
"This clinical trial, to be observed over a 12 month period, aims to monitor the quantity of patients who experience any adverse reactions caused by treatment. Secondary objectives are evaluating changes in milk-specific immunoglobulin E (IgE) levels, whether participants can ingest 2 grams of unheated milk protein after two years and alterations in skin prick test responses regarding milk sensitivity."
Answered by AI
Are there any vacancies available for participants in this trial?
"According to the clinicaltrials.gov website, this specific medical trial is no longer actively searching for test subjects as it was last updated on November 7th 2022. Nevertheless, 259 other trials are still recruiting volunteers at present time."
Answered by AI
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