Boiled Peanut Oral Immunotherapy for the Treatment of Peanut Allergy: a Pilot Study (NCT02149719) | Clinical Trial Compass
CompletedNot Applicable
Boiled Peanut Oral Immunotherapy for the Treatment of Peanut Allergy: a Pilot Study
United Kingdom47 participantsStarted 2015-05
Plain-language summary
Peanut allergy is increasingly common, especially in countries such as UK and Australia. There is currently no accepted routine clinical therapy to cure peanut allergy. Recently studies have looked at desensitising people with peanut allergy by giving them small daily doses of roasted peanut. Although this therapy works for some people, its effects are not generally long lasting and it is associated with many side effects during protocol, resulting in a significant rate of drop-outs.
Pilot data suggests that boiled peanut is less immunogenic than roasted peanut, and may therefore provide a safer way of inducing desensitisation in patients who are allergic to roasted peanut, by first inducing tolerance to boiled peanut.
Study hypothesis: Increasing doses of boiled peanut can induce desensitisation to roasted peanut, in peanut-allergic individuals.
Who can participate
Age range
8 Years – 16 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:
* IgE-mediated peanut allergy, confirmed at double-blind placebo-controlled food challenge
* Tolerant to at least 1/4 boiled peanut (boiled for 4 hours) at open food challenge.
* Informed consent of parent/legal guardian and patient assent
Exclusion Criteria:
* Allergic to 1/4 boiled peanut at PCFC
* Tolerates ≥1.4 g roasted peanut protein at entry PCFC
* Unstable asthma
* Unwilling or unable to fulfil study requirements
* Undergoing other forms of immunotherapy (e.g. SCIT or SLIT to aeroallergens)
* Previous admission to ICU for management of allergic reaction to peanut
* Clinically significant chronic illness (other than asthma, rhinitis or eczema).
* Undergoing subcutaneous or sublingual immunotherapy and within the first year of therapy, for respiratory allergy.
* Subjects receiving anti-IgE therapy, oral immunosupressants, beta-blocker or ACE inhibitor therapy.
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
Desensitisation to >1.4g (Roasted) Peanut Protein at Food Challenge