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

Who is this study for? Child or teenage patients that have had Atopic Dermatitis, have a high IgE level, might have a milk and/or peanut allergy, and are in another NIH study
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 2
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. ...

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 21
Healthy Volunteers: f
View:

‣ 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 procedure. Use of topical steroids will be allowed

⁃ Able to provide informed consent.

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Ellen Zektser, R.N.
ellen.zektser@nih.gov
(301) 761-7565
Backup
Pamela A Guerrerio, M.D.
pamela.guerrerio@nih.gov
(301) 402-9782
Time Frame
Start Date: 2019-04-19
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 200
Treatments
Experimental: Milk DBPCFC
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.
Experimental: One-Step Open Feeding
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.
Experimental: Peanut DBPCFC
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.
Experimental: Two-Step Open Feeding
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.
Related Therapeutic Areas
Sponsors
Leads: National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators: National Institutes of Health Clinical Center (CC)

This content was sourced from clinicaltrials.gov