CompletedNot Applicable

Evaluation of Allergenicity of Hypoallergenic Peanut Product in Peanut Allergic Subjects

United States22 participantsStarted 2011-12

Plain-language summary

This is a proof of concept study to determine the safety and allergenicity of hypoallergenic peanut product extract as compared to standard peanut extract in an adult population with known peanut allergy. This will be assessed by epicutaneous skin prick testing. The hypothesis is that subjects with previously diagnosed peanut allergy will have less epicutaneous reactions to the hypoallergenic peanut product extract.

Who can participate

Age range

18 Years – 65 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

. Specific allergy to peanut confirmed by positive immediate skin test response.
. Oxygen saturation of \> 94 % at baseline
. Blood pressure within the following parameters (Systolic between 140 - 90, Diastolic between 90-60 mm Hg)
. Must be willing and medically able to withhold antihistamine treatment (both H1 and H2) for 3 days prior to starting study medication, and for the duration of the treatment period. Any subject will be told to resume their antihistamine treatment if symptoms require resuming medication.

Exclusion criteria

. Any chronic medical condition including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, chronic thyroid disease, kidney disease or coagulation defects. Asthma is not an exclusion criterion.

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

Size of wheal with epicutaneous testing using non-hypoallergenic extracts.

Timeframe: 20 minutes

Trial details

NCT IDNCT01489514

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2013-01

View on ClinicalTrials.gov More Peanut Allergy trials