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||18 Years - 40 Years|
Inclusion Criteria:For peanut OIT patients: Adults aged 18-40 years with: 1. A positive skin prick test to peanut extract. 2. Elevated (>0.35) serum specific Immunoglobulin E (IgE) to Ara h 2 major peanut allergen within 2 years of date of initial screening visit. 3. Positive DBPCFC to 300mg or less of peanut protein. 4. Where appropriate, use of effective form of birth control by females for the duration of participation in the study (i.e. up to exit DBPCFC). 5. Participants with asthma may be included if well controlled:
- - Asthma control questionnaire (ACQ) score <1.
- - Maximum permitted asthma treatment: moderate dose of inhaled corticosteroid (ICS) and long-acting beta agonists (LABA) as treatment.
- - Pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1) >80% of predicted value at screening visit.
- - For asthmatic participants with intermittent mild symptoms (induced by exercise, animals or pollens) using as required salbutamol only, treatment will be given with regular low dose inhaled corticosteroids (ICS) prior to challenges and for the duration of updosing as an additional measure.
Exclusion Criteria:For peanut OIT patients: 1. Anaphylaxis to a food other than peanut
- - despite attempted avoidance - within the last 2 years.
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.
|Guy's and St Thomas' NHS Foundation Trust|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Stephen J Till, MA FRCP PhD|
|Principal Investigator Affiliation||Guy's and St Thomas' NHS Foundation Trust / King's College London|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
25 adults with peanut allergy, as confirmed by double blind placebo controlled food challenge (DBPCFC), will undergo peanut oral immunotherapy (OIT) with peanut flour. An additional 15 untreated peanut allergic adults will be recruited as comparator group for skin prick tests and mechanistic studies/immunological assays.
Experimental: Peanut oral immunotherapy
Desensitisation using peanut flour
Other: - Peanut oral immunotherapy
Daily doses of peanut flour (with 2-weekly incremental interval)
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