N/A
Completed N=47
Boiled Peanut Oral Immunotherapy for the Treatment of Peanut Allergy: a Pilot Study
IgE Mediated Peanut Allergy
Source: ClinicalTrials.gov NCT02149719 ↗
Enrolled (actual)
47
Serious AEs
41.9%
Results posted
Mar 2024
Primary outcomePrimary: Desensitisation to >1.4g (Roasted) Peanut Protein at Food Challenge — 24; 14 Participants — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Desensitisation to >1.4g (Roasted) Peanut Protein at Food Challenge |
24; 14 | <0.0001 sig |
| SECONDARY Change in Threshold to Roasted Peanut After 6 and 12 Months of OIT |
— | — |
| SECONDARY Sustained Unresponsiveness After 4 Week Cessation of Maintenance OIT |
— | — |
| SECONDARY Safety, Incidence of Adverse Event |
— | — |
| SECONDARY Quality of Life Measures |
— | — |
| SECONDARY Study Compliance |
— | — |
| SECONDARY Immunological Outcomes |
— | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02149719). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.