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DBV1605 Diagnostic Test for Cow's Milk Allergy (APTITUDE Trial)
APTITUDE Trial Summary
This trial is testing a new method for diagnosing non-IgE mediated cow's milk allergy in children with symptoms suggestive of the allergy.
APTITUDE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowAPTITUDE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.APTITUDE Trial Design
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Who is running the clinical trial?
Media Library
- I have ongoing stomach or intestinal problems.I have been consuming cow's milk or started a cow's milk elimination diet less than 4 weeks ago.I am a child aged between 1 month and 2 years.I am between 1 month and 2 years old.I am between 1 month and 2 years old.I show symptoms that suggest I might have a non-IgE milk allergy.You are able to consume at least 200 mL of cow's milk or equivalent dairy products daily for 4 weeks before the screening visit.I show symptoms that suggest I might have a non-IgE milk allergy.My condition falls into a specific disease group.I consume cow's milk or started a cow's milk elimination diet less than 4 weeks ago.
- Group 1: Disease group
- Group 2: Control group
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Am I qualified to partake in this experiment?
"This clinical study is recruiting a total of 230 infants and toddlers between 29 days to 24 months with cow's milk allergies. Furthermore, they must have been exhibiting symptoms that suggest non-IgE mediated Cow’s Milk Allergy, as well as agree to follow the prescribed diet plan consisting of no use of cow's milk products or other mammalian milks (e.g., sheep and goat). Additionally male or female participants should not have started any sort of dietary regimen containing daily products with cow’s milk protein in the four weeks leading up to screening visit."
How many individuals are enrolled in this medical trial?
"In order to reach the recruitment target of 230, participants must meet certain criteria. These patients may take part in this trial at Alliance for Multispecialty Research, LLC - New Roy Office (Roy, Utah) or Children's Hospital of Philadelphia (Philadelphia, Pennsylvania)."
How many health care facilities are presently conducting this research in the state?
"Currently, 24 medical centres are recruiting patients for this trial. These range from the Alliance for Multispecialty Research in Roy to Halton Pediatric Allergy located in Burlington and other locations scattered across America."
Is this trial actively recruiting participants at this time?
"According to the clinicaltrials.gov portal, this medical experiment is currently searching for volunteers and was first published on August 28th 2020 with its most recent update made two years later on August 9th 2022."
Is this medical trial enrolling individuals who are younger than sixty years old?
"For this medical study, participants must be between 29 Days and 24 Months of age. Additionally, there are 85 trials for minors and 156 trials available to seniors."
Has the FDA granted its authorization for DBV1605?
"DBV1605 has been assigned a safety score of 2, as prior clinical data exists to support its safety but no efficacy results have yet been obtained."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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