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IgE Threshold Testing for Food Allergy

Phase 2

Recruiting

Led By Fernanda D Young, M.D.

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 3-21 years.

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up oral food challenge visits

Awards & highlights

Study Summary

This trial is testing whether people with atopic dermatitis are truly allergic to milk and/or peanuts.

Who is the study for?

This trial is for children and young adults aged 3-21 with atopic dermatitis (eczema) who may have milk or peanut allergies, a high total IgE level, and are part of another NIH study. They must be willing to stop certain allergy medications before food challenges.Check my eligibility

What is being tested?

The trial tests if participants with eczema are truly allergic to milk or peanuts by giving them increasing amounts of these foods or placebos in controlled settings. The goal is to improve food allergy testing methods.See study design

What are the potential side effects?

Potential side effects include allergic reactions during the oral food challenge, ranging from mild symptoms like itching to more severe reactions that could require medical intervention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 3 and 21 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ oral food challenge visitsv

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~oral food challenge visitsv

This trial's timeline: 3 weeks for screening, Varies for treatment, and oral food challenge visitsv for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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.

Secondary outcome measures

Basophil and mast cell reactivity and other exploratory markers.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Two-Step Open FeedingExperimental Treatment4 Interventions

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.

Group II: Peanut DBPCFCExperimental Treatment2 Interventions

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.

Group III: One-Step Open FeedingExperimental Treatment4 Interventions

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.

Group IV: Milk DBPCFCExperimental Treatment2 Interventions

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.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,270 Previous Clinical Trials

5,485,037 Total Patients Enrolled

12 Trials studying Food Allergy

12,258 Patients Enrolled for Food Allergy

National Institutes of Health Clinical Center (CC)NIH

383 Previous Clinical Trials

880,802 Total Patients Enrolled

Fernanda D Young, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)

Media Library

One-Step Open Feeding Clinical Trial Eligibility Overview. Trial Name: NCT03835767 — Phase 2

Food Allergy Research Study Groups: Milk DBPCFC, One-Step Open Feeding, Two-Step Open Feeding, Peanut DBPCFC

Food Allergy Clinical Trial 2023: One-Step Open Feeding Highlights & Side Effects. Trial Name: NCT03835767 — Phase 2

One-Step Open Feeding 2023 Treatment Timeline for Medical Study. Trial Name: NCT03835767 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can I partake in this investigation?

"This medical trial is recruiting 200 children aged 3 to 21 with a documented history of food hypersensitivity. Other eligibility criteria include having an assigned primary care doctor and being enrolled in the 15-I-0162 study, as well as discontinuing use of omalizumab or dupilumab within 6 months of a food challenge and ceasing oral steroids prior to testing. Moreover, patients must be willing to partake in an oral food challenge for both placebo and test foods while still permitted topical steroid usage."

Answered by AI

Does the age of participants in this study extend beyond thirty years?

"This clinical trial requires that potential participants be aged between 3 and 21. It is one of 183 studies available for those below 18 years old, and the number increases to 322 when considering patients above 65."

Answered by AI

How many individuals are participating in this research endeavor?

"Affirmative. Clinicaltrials.gov states that this clinical trial is actively seeking candidates, which was initially posted on April 19th 2019 and revised most recently on November 18th 2022. 200 patients must be enlisted from a single site for the study to proceed."

Answered by AI

Is enrollment still available for those interested in participating?

"According to the records hosted by clinicaltrials.gov, this medical study is still seeking participants and was first posted on April 19th 2019 with its last edits being made in November 18th 2022."

Answered by AI

To what extent might there be adverse effects to utilizing Peanut DBPCFC?

"Peanut DBPCFC's safety rating was assigned a score of 2 on the 1-3 scale. Although there are some studies indicating its security, no efficacy data is available as this trial is yet in Phase 2."

Answered by AI

Recent research and studies

The Journal of PediatricsJournal

Oral Food Challenges in Children with a Diagnosis of Food Allergy

Fleischer, David M., S. Allan Bock, Gayle C. Spears, Carla G. Wilson, Naomi K. Miyazawa, Melanie C. Gleason, Elizabeth A. Gyorkos, James R. Murphy, Dan Atkins, and Donald Y.M. Leung. 2011. “Oral Food Challenges in Children with a Diagnosis of Food Allergy”. The Journal of Pediatrics. Elsevier BV. doi:10.1016/j.jpeds.2010.09.027.

Journal of Allergy and Clinical ImmunologyJournal

Standardizing Double-blind, Placebo-controlled Oral Food Challenges: American Academy of Allergy, Asthma & Immunology–european Academy of Allergy and Clinical Immunology PRACTALL Consensus Report

Sampson, Hugh A., Roy Gerth van Wijk, Carsten Bindslev-Jensen, Scott Sicherer, Suzanne S. Teuber, A. Wesley Burks, Anthony E.J. Dubois, et al.. 2012. “Standardizing Double-blind, Placebo-controlled Oral Food Challenges: American Academy of Allergy, Asthma & Immunology–european Academy of Allergy and Clinical Immunology PRACTALL Consensus Report”. Journal of Allergy and Clinical Immunology. Elsevier BV. doi:10.1016/j.jaci.2012.10.017.

The Journal of Allergy and Clinical Immunology: In PracticeJournal

Oral Food Challenge and Food Allergy Quality of Life in Caregivers of Children with Food Allergy

Franxman, Timothy J., Laura Howe, Esther Teich, and Matthew J. Greenhawt. 2015. “Oral Food Challenge and Food Allergy Quality of Life in Caregivers of Children with Food Allergy”. The Journal of Allergy and Clinical Immunology: In Practice. Elsevier BV. doi:10.1016/j.jaip.2014.06.016.

clinicaltrials.govStudy