None listed
Conditions
Brief summary
Peanut allergy affects more than 1% of the Australian population and the prevalence is increasing. To date, there is no effective treatment. This pilot study will test the safety and effectiveness in peanut allergic children of a biphasic oral immunotherapy using increasing doses of boiled peanuts followed by increasing doses of raw/roasted peanuts. Results from this pilot study will be used to design a large multi-centre randomised controlled trial.
Interventions
Following confirmation of peanut allergy by a positive open food challenge test, patients aged 6 - 16 will be treated with increasing dosage of boiled peanuts starting with 1/4 of a boiled peanut per day for week 1; 1/4 of a boiled peanut twice a day for week 2 and 1/4 of a boiled peanut 3 times per day for week 3. For subsequent weeks, doses will be increased weekly up to target dose of 10 boiled peanuts in 3 divided doses per day at week 18. This dosage will be maintained for 3.5 months and
Following confirmation of peanut allergy by a positive open food challenge test, patients aged 6 - 16 will be treated with increasing dosage of boiled peanuts starting with 1/4 of a boiled peanut per day for week 1; 1/4 of a boiled peanut twice a day for week 2 and 1/4 of a boiled peanut 3 times per day for week 3. For subsequent weeks, doses will be increased weekly up to target dose of 10 boiled peanuts in 3 divided doses per day at week 18. This dosage will be maintained for 3.5 months and then patients will return for their first dose of raw peanut, which will be 1/4 of a raw peanut and will be escalated using the same regime as for boiled peanuts until the patients can ingest 10 raw peanuts per day at 18 weeks from the first dose of raw peanut. The dosage will be gradually increased to 10 raw peanuts per day when this dosage will be maintained indefinitely. Treatment compliance and adverse events will be monitored by use of a diary.
Sponsors
Dr Billy Tao
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
6 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
Patients who are proven to be allergic to peanut by a positive open food challenge test immediately prior to enrolment into the study.
Exclusion criteria
1. Serious medical co-morbidities. 2. Initial allergic reaction to peanut was life threatening. 3. Parents unable to supervise treatment or unwilling to sign informed consent.
Outcome results
None listed