Boiled Peanut Oral Immunotherapy for the Treatment of Peanut Allergy: a Pilot Study

NCT02149719 | Completed Results DMC

• 2 other identifiers: 15SM2492ACTRN12614000265673
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

IgE Mediated Peanut Allergy

Keywords

Peanut allergy; Desensitisation; Safety

Outcome Measures

Primary Outcomes (1)

• Desensitisation to >1.4g (Roasted) Peanut Protein at Food Challenge

  The proportion of participants who tolerate 1.4g (or more) roasted peanut protein after 12 months of OIT as assessed by DBPCFC, in the active vs control group.

  12 months

Secondary Outcomes (6)

• Change in Threshold to Roasted Peanut After 6 and 12 Months of OIT

  6 and 12 months after study intervention

• Sustained Unresponsiveness After 4 Week Cessation of Maintenance OIT

  After 1 year of OIT

• Safety, Incidence of Adverse Event

  12 months

• Quality of Life Measures

  6, 12 and 24 months

• Study Compliance

  12 months

Other Outcomes (1)

• Change in Threshold in Peanut-allergic Subjects Found to be Tolerant to Boiled Peanut at Baseline

  12 months

Study Arms (2)

Desensitisation to peanut

EXPERIMENTAL

Desensitisation using boiled peanut

Other: Desensitisation using boiled peanut

Control

EXPERIMENTAL

Subjects allocated to the control group will undergo routine care for 12 months, following which they will be offered the active treatment with boiled peanut (as a one-way cross-over intervention).

Other: Desensitisation using boiled peanut (deferred start)

Interventions

Desensitisation using boiled peanut OTHER

Desensitisation to peanut

Desensitisation using boiled peanut (deferred start) OTHER

Control

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College London: lead
• University of Sydney: collaborator
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Imperial College London / Imperial College Healthcare NHS Trust

London, W2 1NY, United Kingdom

Location

Related Publications (2)

• Turner PJ, Ruiz-Garcia M, Patel N, Abrantes G, Burrell S, Vazquez-Ortiz M, Skypala I, Durham SR, Boyle RJ. Delayed symptoms and orthostatic intolerance following peanut challenge. Clin Exp Allergy. 2021 May;51(5):696-702. doi: 10.1111/cea.13865. Epub 2021 Mar 21.

  PMID: 33715235 DERIVED

• Burrell S, Patel N, Vazquez-Ortiz M, Campbell DE, DunnGalvin A, Turner PJ. Self-administration of adrenaline for anaphylaxis during in-hospital food challenges improves health-related quality of life. Arch Dis Child. 2021 Jun;106(6):558-563. doi: 10.1136/archdischild-2020-319906. Epub 2020 Sep 18.

  PMID: 32948514 DERIVED

MeSH Terms

Conditions

Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Dr Paul Turner
• Organization: Imperial College London

p.turner@imperial.ac.uk

+44 20 3312 7754

Study Officials

• Dianne E Campbell, FRACP PhD

  The Children's Hospital at Westmead, Australia

  STUDY CHAIR

• Sam Mehr, FRACP

  The Children's Hospital at Westmead, Australia

  STUDY DIRECTOR

• Paul J Turner, FRACP PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 24, 2014
• First Posted: May 29, 2014
• Study Start: May 1, 2015
• Primary Completion: November 30, 2020
• Study Completion: May 12, 2022
• Last Updated: March 29, 2024
• Results First Posted: March 29, 2024

Record last verified: 2024-03

Locations

GB (1)