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Boiled Peanut Oral Immunotherapy for the Treatment of Peanut Allergy: a Pilot Study
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.
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
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|Eligible Ages||8 Years - 16 Years|
- - 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Imperial College London|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Dianne E Campbell, FRACP PhDSam Mehr, FRACPPaul J Turner, FRACP PhD|
|Principal Investigator Affiliation||The Children's Hospital at Westmead, AustraliaThe Children's Hospital at Westmead, AustraliaImperial College London|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Active, not recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
|IgE Mediated Peanut Allergy|
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Imperial College London / Imperial College Healthcare NHS Trust
London, , W2 1NY