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New treatment option for Milk and/or Peanut Allergy
Official title Food-Specific and Component IgE Threshold Levels That Predict Food Allergy in People With Elevated Total Serum IgE Levels and Atopic Dermatitis
ClinicalTrials.gov ID: NCT03835767
What this study is testing
- What it's testing
- Background: Atopic dermatitis (AD), also called eczema, makes skin dry, red, and itchy. People with AD are more likely to get a food allergy than people without AD.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 21
You may be able to join if
- Individuals must meet all of the following criteria to be eligible for study participation:
- Aged 3-21 years.
- Currently enrolled on study 15-I-0162, "Natural History and Genetics of Food Allergy and Related Conditions."
- Has a total serum IgE level \>= 900 kU/L at time of screening.
- Has a history of AD based on self-report or physician assessment.
See the full eligibility criteria
- Individuals must meet all of the following criteria to be eligible for study participation:
- Aged 3-21 years.
- Currently enrolled on study 15-I-0162, "Natural History and Genetics of Food Allergy and Related Conditions."
- Has a total serum IgE level \>= 900 kU/L at time of screening.
- Has a history of AD based on self-report or physician assessment.
- Willing to undergo an oral food challenge to both placebo and test food.
- Willing to allow storage of blood samples for future use in medical research.
- Willing to allow genetic testing to be conducted on blood samples.
- Has a primary care physician or other physician who will manage all health conditions related or unrelated to the study objectives.
- Be willing to discontinue omalizumab or dupilumab within 6 months of a food challenge,and antihistamines and oral steroids prior to a food challenge, as these drugs might interfere with the oral food challenge...
- Able to provide informed consent. EXCLUSION CRITIERIA: Individuals meeting any of the following criteria will be excluded from study participation:
- Pregnant.
- Known genetic disorder that causes an elevation in total IgE level or one that could affect the severity of an anaphylactic response.
- Known cardiac disease.
- Current use of a beta-blocker.
- Active eosinophilic gastrointestinal (GI) disorder including eosinophilic esophagitis, currently symptomatic, unless they are currently on treatment and have had a negative esophageal biopsy via endoscopy within at...
- Any chronic medical condition requiring long-term use of oral steroids.
- Current or recent (within previous 6 months) use of omalizumab or dupilumab.
- Any condition that, in the opinion of the investigator, contraindicates participation in this study. Co-enrollment guidelines: Co-enrollment in other trials is restricted, other than enrollment on observational studies...
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.