Accepts Healthy Volunteers
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.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||7 Years - 18 Years|
- - Age 7-18 years (enrolment up to a participant's 19th birthday).
- - Past history consistent with IgE-mediated peanut allergy.
- - Allergic to ≤1.44 g peanut protein (approx.
- - Tolerates at least 1/8 boiled peanut (boiled for 4 hours) at open food challenge at screening.
- - Written informed consent of parent/legal guardian and patient assent.
- - Required previous admission to an intensive care unit for management of an allergic reaction to peanut.
- - Clinically significant chronic illness (other than asthma, rhinitis or eczema).
- - Undergoing subcutaneous or sublingual immunotherapy to respiratory allergens, and not yet established on maintenance dosing for at least 3 months.
- - Undergoing oral immunotherapy for food allergy and within the first year of treatment.
- - Subjects receiving anti-IgE therapy, oral immunosuppressants, beta-blocker or ACE inhibitor.
- - Tolerance to ≥1.44 g peanut protein (approx.
- - Dose-limiting symptoms to 1/8 boiled peanut (boiled for 4 hours) at screening.
- - Poorly controlled asthma within the previous 3 months (as defined by clinician judgement with reference to the ICON consensus ), or asthma requiring treatment with >5 days oral corticosteroids within the previous 3 months.
- - Pregnancy.
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.
|Paul J Turner, FRACP PhD|
|Principal Investigator Affiliation||Imperial 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, Peanut Hypersensitivity|
|Study Website:||View Trial Website|
Experimental: Boiled peanut Oral Immunotherapy
Desensitisation using boiled peanut
Active Comparator: Conventional Oral immunotherapy
Desensitisation using defatted peanut flour
Other: - Boiled peanut
Desensitisation using boiled peanut for induction and initial updosing
Other: - Defatted roasted peanut flour
Desensitisation using defatted peanut flour for induction and initial updosing
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Imperial College Healthcare NHS Trust (St. Mary's Hospital)