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NCT03835767 · ClinicalTrials.gov registry record · Phase 2
Food-Specific and Component IgE Threshold Levels That Predict Food Allergy in People With Elevated Total Serum IgE Levels and Atopic Dermatitis
A Phase 2 study of Milk and/or Peanut Allergy, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT03835767: Recruiting Phase 2 study of Milk and/or Peanut Allergy, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03835767 is a Phase 2 study of Milk and/or Peanut Allergy that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 200 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03835767, a Phase 2 study of Milk and/or Peanut Allergy, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
- 1
- Study location
Study 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. ...
Primary Outcome
To estimate ROC curves for food specific and component IgE threshold levels in patients with elevated total serum IgE and a history of AD, to determine a subgroup with at least a 50% likelihood of tolerance to peanut and/or milk, via use of oral food challenges, and to estimate other diagnostic metrics (sensitivity and specificity) associated with this 50% risk threshold.
Conditions Studied
Interventions
- OTHER Peanut powder and Oat flour
- OTHER Peanut flour and Oat flour (placebo for peanut flour)
- OTHER Dry Milk Powder and Corn Starch (placebo for Milk powder)
- OTHER Baked milk and Rice milk (placebo for Baked milk)
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2019-04-19 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
What NCT03835767 shows while recruiting
NCT03835767 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% higher).
The record links to 1 condition, with Milk and/or Peanut Allergy appearing as the primary indexed condition, and to 4 interventions - of which Peanut powder and Oat flour is the first listed.
NCT03835767 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03835767 about?
NCT03835767 is a clinical study titled "Food-Specific and Component IgE Threshold Levels That Predict Food Allergy in People 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 ...
What is the current status of trial NCT03835767?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2019-04-19. Estimated completion is 2027-12-31.
What conditions does trial NCT03835767 study?
This clinical trial studies the following conditions: Milk and/or Peanut Allergy.
What interventions are being tested in trial NCT03835767?
The interventions under investigation include: Peanut powder and Oat flour (OTHER), Peanut flour and Oat flour (placebo for peanut flour) (OTHER), Dry Milk Powder and Corn Starch (placebo for Milk powder) (OTHER), Baked milk and Rice milk (placebo for Baked milk) (OTHER).
Who is sponsoring clinical trial NCT03835767?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03835767 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03835767's enrollment target sits among peer trials
200 304th of 2000 higher than 1,652 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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