Food Allergen OIT for Shrimp and Cashew (NCT03504774) | Clinical Trial Compass
TerminatedPhase 2
Food Allergen OIT for Shrimp and Cashew
Stopped: Study discontinued due to slow enrollment during COVID-19 pandemic
United States58 participantsStarted 2019-07-09
Plain-language summary
A prospective Phase 2, single-center, single-allergen OIT of cashew or shrimp in participants with proven allergies to either cashew or shrimp, respectively. We intend to treat 72 participants, ages 7 to 55 years with an allergy to either cashew, or shrimp determined by Double Blind-Placebo Controlled-Food Challenge (DBPCFC), allergy history, clinical symptoms, food-allergen (FA)-specific IgE levels, and skin prick test (SPT).
Who can participate
Age range
7 Years – 55 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:
* Subject and/or parent guardian must be able to understand and provide informed consent
* Age 7 through 55 years (inclusive)
* Clinical history of allergy to cashew or shrimp-containing foods
* Serum IgE to cashew or shrimp of ≥0.35 kUA/L \[determined by UniCAPTM within the past 12 months\] and/or a SPT to cashew or shrimp ≥3 mm compared to control
* Experience dose-limiting symptoms at or before the 300 mg challenge dose of FA protein on Screening DBPCFC conducted in accordance with PRACTALL guidelines
* Written informed consent from adult participants
* Written informed consent from parent/guardian for minor participants
* Written assent from minor participants as appropriate (e.g., above the age of 7 years or the applicable age per local regulatory requirements)
* All female subjects of child-bearing potential will be required to provide a blood or urine sample for pregnancy testing that must be negative one week before being allowed to participate in the study.
* Use of effective birth control by female participants of child-bearing potential.
Exclusion Criteria:
* Inability or unwillingness of a participant to give written informed consent or comply with study protocol
* History of uncontrolled cardiovascular disease, including uncontrolled hypertension
* History of other chronic disease (other than asthma, atopic dermatitis, or allergic rhinitis) requiring therapy (e.g., heart disease, diabetes) that is, or is at significant risk of becoming unst…
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
1
Expression of CD28 in the CD4+ Allergen Specific (CD154+)