Phase 1
N=8
Boiled Peanut Oral Immunotherapy
Peanut Hypersensitivity
Bottom Line
View on ClinicalTrials.gov: NCT04090203 ↗Enrolled (actual)
8
Serious AEs
25.0%
Results posted
Sep 2024
Primary outcome: Primary: Increase in Tolerance to Peanut in Pediatric Patients With Peanut Hypersensitivity Reported as the Percentage of Participants Successfully Desensitized. — 75 percentage of participants — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Boiled Peanut Powder (Drug)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- Alton Melton
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Increase in Tolerance to Peanut in Pediatric Patients With Peanut Hypersensitivity Reported as the Percentage of Participants Successfully Desensitized. |
75 | 0.001 sig |
Summary
Prospective Phase 1 clinical trial providing proof of concept data on boiled peanut oral immunotherapy (OIT) for the treatment of peanut allergy in children. The investigators hypothesize that the proportion of subjects successfully desensitized with boiled peanut OIT is greater than the theoretical placebo rate of 20%.
Eligibility Criteria
Inclusion Criteria
- Age 1-16 years
- History of immediate hypersensitivity reaction to peanut
- Evidence of IgE mediated peanut hypersensitivity within a 12 month period of study enrollment
- SPT with wheal/flare of at least 3 x 6 mm and/or Peanut specific IgE >0.35 kU/L
Exclusion Criteria
- History of life threatening peanut anaphylaxis
- Asthma requiring more than medium dose ICS
- Prior participation in oral immunotherapy, sublingual immunotherapy or epicutaneous immunotherapy
- Oat allergy
- Cardiovascular Disease
- Use of beta-blockers (oral), angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or calcium channel blockers
- Use of steroid medications in the following manners:
- Daily oral steroid dosing for greater than 1 month during the past year
- Burst or steroid course in the past 3 month before inclusion
- Greater than 2 bursts oral steroid courses in the past year of at least 1 week duration
- Pregnancy or lactation
- Eosinophilic Gastrointestinal Disease
- History of food protein-induced enterocolitis
- History of developmental delay or speech delay that precludes age- appropriate communication, in the opinion of the investigator
Data sourced from ClinicalTrials.gov (NCT04090203). 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.