Food-Specific and Component IgE Threshold Levels That Predict Food Allergy in People With Elevated Total Serum IgE Levels and Atopic Dermatitis
| Status: | Recruiting |
|---|---|
| Conditions: | Allergy, Allergy, Allergy, Allergy, Neurology, Dermatology, Dermatology, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Neurology, Otolaryngology |
| Healthy: | No |
| Age Range: | 3 - 21 |
| Updated: | 4/6/2019 |
| Start Date: | April 10, 2019 |
| End Date: | December 31, 2028 |
| Contact: | Caeden Dempsey |
| Email: | caeden.dempsey@nih.gov |
| Phone: | (301) 761-7887 |
Prospective Study to Identify Food-Specific and Component IgE Threshold Levels That Predict Food Allergy in Patients With Elevated Total Serum IgE Levels and Atopic Dermatitis
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.
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.
Allergy skin prick tests and measurement of food-specific immunoglobulin E (IgE) levels are
common but not robust means to diagnose food allergy, so patients may be placed on overly
restrictive food elimination diets as a result of false-positive results. Such restrictions
can lead to poor weight gain, malnutrition, and negative impact on quality of life. More than
half of patients who are sensitized (ie, have a positive IgE test) to a particular food do
not react to it during an oral food challenge, the gold standard for diagnosing food allergy.
Development of food allergy does not always correlate to food-specific IgE levels. The care
of these patients would be dramatically improved if decision points for food-specific or
component IgEs could be identified that predict when an immediate hypersensitivity is
present. This is especially an issue among patients with atopic dermatitis (AD), the most
common chronic, relapsing inflammatory disorder of the skin affecting children. Patients with
AD are more likely to develop other allergic conditions, including food allergy and
sensitization. AD patients are also likely to have high levels of total serum IgE.
In this study, participants aged 3-21 years (n = 175) with elevated total serum IgE levels
and a history of AD will undergo open feedings and/or double-blind, placebo-controlled food
challenges (DBPCFCs). Open feedings will be 1- or 2-step, depending on how often the
participant regularly consumes the food at home. There are two DBPCFCs to milk: milk powder
or rice milk (placebo) baked into a muffin, and straight milk powder or corn starch (placebo)
mixed with a vehicle. The DBPCFC for peanut will be done with peanut flour or oat flour
(placebo) mixed with a vehicle. Blood will be collected during the study for measurement of
total and component IgEs as well as potential biomarkers of food sensitization vs. immediate
hypersensitivity and reaction severity. From these data, we hope to identify diagnostic IgE
threshold levels that will inform when oral food challenges are warranted in patients with
elevated total serum IgE levels and AD, which is critically needed in the allergy field to
facilitate the care of these patients.
common but not robust means to diagnose food allergy, so patients may be placed on overly
restrictive food elimination diets as a result of false-positive results. Such restrictions
can lead to poor weight gain, malnutrition, and negative impact on quality of life. More than
half of patients who are sensitized (ie, have a positive IgE test) to a particular food do
not react to it during an oral food challenge, the gold standard for diagnosing food allergy.
Development of food allergy does not always correlate to food-specific IgE levels. The care
of these patients would be dramatically improved if decision points for food-specific or
component IgEs could be identified that predict when an immediate hypersensitivity is
present. This is especially an issue among patients with atopic dermatitis (AD), the most
common chronic, relapsing inflammatory disorder of the skin affecting children. Patients with
AD are more likely to develop other allergic conditions, including food allergy and
sensitization. AD patients are also likely to have high levels of total serum IgE.
In this study, participants aged 3-21 years (n = 175) with elevated total serum IgE levels
and a history of AD will undergo open feedings and/or double-blind, placebo-controlled food
challenges (DBPCFCs). Open feedings will be 1- or 2-step, depending on how often the
participant regularly consumes the food at home. There are two DBPCFCs to milk: milk powder
or rice milk (placebo) baked into a muffin, and straight milk powder or corn starch (placebo)
mixed with a vehicle. The DBPCFC for peanut will be done with peanut flour or oat flour
(placebo) mixed with a vehicle. Blood will be collected during the study for measurement of
total and component IgEs as well as potential biomarkers of food sensitization vs. immediate
hypersensitivity and reaction severity. From these data, we hope to identify diagnostic IgE
threshold levels that will inform when oral food challenges are warranted in patients with
elevated total serum IgE levels and AD, which is critically needed in the allergy field to
facilitate the care of these patients.
- INCLUSION CRITERIA:
Individuals must meet all of the following criteria to be eligible for study participation:
1. Aged 3-21 years.
2. Currently enrolled on study 15-I-0162, Natural History and Genetics of Food Allergy
and Related Conditions.
3. Has a total serum IgE level > 1000 kU/L at time of screening.
4. Has a history of AD based on self-report or physician assessment.
5. Willing to undergo an oral food challenge to both placebo and test food.
6. Willing to allow storage of blood samples for future use in medical research.
7. Willing to allow genetic testing to be conducted on blood samples.
8. Has a primary care physician or other physician who will manage all health conditions
related or unrelated to the study objectives.
9. Be willing to discontinue any medication (eg, oral antihistamines and oral steroids)
that might interfere with the oral food challenge procedure within an appropriate time
frame.
10. Able to provide informed consent.
EXCLUSION CRITIERIA:
Individuals meeting any of the following criteria will be excluded from study
participation:
1. Pregnant.
2. Documented allergy or other contraindication to rice, corn, or oat products.
3. Known genetic disorder that causes an elevation in total IgE level or one that could
affect the severity of an anaphylactic response.
4. Known cardiac disease.
5. Current use of a beta-blocker.
6. 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 the past 6 months.
7. Current or recent (within previous 2 months) use of omalizumab or dupilumab.
8. Any condition that, in the opinion of the investigator, contraindicates participation
in this study.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
301-496-2563
Phone: 800-411-1222
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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