Food-Specific and Component IgE Threshold Levels That Predict Food Allergy in People With Elevate… (NCT03835767) | Clinical Trial Compass
RecruitingPhase 2
Food-Specific and Component IgE Threshold Levels That Predict Food Allergy in People With Elevated Total Serum IgE Levels and Atopic Dermatitis
United States200 participantsStarted 2019-04-19
Plain-language summary
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. But some food allergy tests are not always accurate in people with AD. Researchers want to study if people are truly allergic to milk and/or peanuts.
Objectives:
To improve the ways doctors test for food allergy in people with AD.
Eligibility:
People ages 3-21 who have had AD; have a high total IgE level (an allergic antibody); might have a milk and/or peanut allergy; and are currently enrolled in another NIH study
Design:
Participants will be screened under another protocol.
Participants will have a physical exam, blood tests, and medical history.
Participants will breathe into a plastic device that measures lung strength.
Participants may get a small plastic tube inserted in their arm.
Participants who have not had an allergic reaction to food in the past 3 years will do 1 or more oral food challenge (OFCs) depending on their allergies.
They will eat a little bit of the food they might be allergic to.
They will be watched for a reaction. If they have one, they will know for sure they are allergic.
They may keep eating bigger portions of the food until they either have a reaction or finish all the food.
In some OFCs, participants will get a placebo food.
OFCs will last a few hours or 2 days. Participants will repeat all tests at each OFC.
Participation can last up to 12 months.
...
Who can participate
Age range
3 Years – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Allergy to milk and peanut status; allowing for estimation of IgE thresholds that determine a subgroup with at least 50% chance of tolerance in patients with elevated total serum IgE levels and history of AD.
Timeframe: Oral Food Challenge Visits
Trial details
NCT IDNCT03835767
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. Has a primary care physician or other physician who will manage all health conditions related or unrelated to the study objectives.
Exclusion criteria
. 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.