Food-Specific and Component IgE Threshold Levels That Predict Food Allergy in People With Elevated Total Serum IgE Levels and Atopic Dermatitis
Milk and/or Peanut Allergy
About this trial
This is an interventional diagnostic trial for Milk and/or Peanut Allergy focused on measuring Oral Food Challenge, Atopic Dermatitis, Milk, Peanut, Food Allergy
Eligibility Criteria
- INCLUSION 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 greater than or equal to 1000 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 procedure. Use of topical steroids will be allowed
- 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 least the past 18 months, and/or unless the study food is already in the participants diets.
- 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.
Sites / Locations
- National Institutes of Health Clinical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Milk DBPCFC
One-Step Open Feeding
Peanut DBPCFC
Two-Step Open Feeding
There are two double blind placebo controlled food challenges. The first challenge is to baked milk. The following participants will undergo this DBPCFC: - All participants who eat baked milk less than once per month. - Participants who never eat baked milk or straight milk. On the first day of this challenge, participants will be randomized to either milk Baked milk or rice milk. Dry milk powder or corn starch. or placebo, and then will be challenged with the other food on the next day.
Participants who are consuming baked milk, straight milk, and/or peanut products at least once per week will do a one-step oral food challenge.
The DBPCFC for peanut allergy will be done with either peanut flour or a placebo (oat flour). The following participants will undergo this DBPCFC: - All participants who eat peanut less than once per month - Participants who never eat peanut On the first day of this challenge, participants will be randomized to either peanut or placebo, and then will be challenged with the other food on the next day.
Participants who consume baked milk, straight milk, and/or peanut products less than once per week but at least once per month will do a two step open oral food challenge.