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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase 2 Randomised Study of Oral Immunotherapy Using Boiled Peanut to Induce Desensitisation in Children With Challenge-proven, IgE-mediated Peanut Allergy

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.


Detailed Summary:
Sponsor: Imperial College London

Current Primary Outcome: Desensitisation to >1.4g (roasted) peanut protein at food challenge [ Time Frame: 12 months ]

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.


Original Primary Outcome: Desensitisation to 433mg (roasted) peanut protein at food challenge [ Time Frame: 12 months ]

Desensitisation to 433mg (or more) roasted peanut protein after 12 months of oral immunotherapy, as assessed by double-blind, placebo-controlled food challenge.


Current Secondary Outcome:

  • Change in threshold to roasted peanut after 6 and 12 months of OIT [ Time Frame: 6 and 12 months after study intervention ]
    Relative change in clinical threshold (No observed adverse event level, NOAEL; Lowest observed adverse event level, LOAEL) to roasted peanut at 6 and 12 months.
  • Sustained unresponsiveness after 4 week cessation of maintenance OIT [ Time Frame: After 1 year of OIT ]
    Rate of sustained unresponsiveness after 4 week cessation of maintenance OIT at 1 year.
  • Safety [ Time Frame: 12 months ]
    Incidence of adverse allergic events during desensitisation protocol
  • Quality of life measures [ Time Frame: 6, 12 and 24 months ]
    Quality of Life assessment and how this changes during peanut desensitisation.
  • Study compliance [ Time Frame: 12 months ]
    Compliance with study protocol
  • Immunological outcomes [ Time Frame: Pre, 3, 6, and 12 months post start of OIT ]
    Immunological outcome measures pre-, during and post- 12 months of OIT


Original Secondary Outcome:

  • Desensitisation (to at least one roasted peanut (>250mg peanut protein)) following updosing using boiled peanut [ Time Frame: One month following successful updosing to 1g boiled peanut protein ]
    Desensitisation to at least one roasted peanut (>250mg peanut protein) following specific oral tolerance induction using boiled peanut, as assessed by double-blind, placebo-controlled food challenge.
  • Change in threshold to roasted peanut protein (compared to baseline) at 12 months [ Time Frame: 12 months ]
    Change in threshold to roasted peanut protein compared to baseline, following 12 months of oral immunotherapy, as assessed by double-blind, placebo-controlled food challenge. Comparison between active and control group.
  • Safety [ Time Frame: 12 months ]
    Incidence of adverse allergic events during desensitisation protocol
  • Quality of life measures [ Time Frame: 6, 12 and 24 months ]
    Quality of Life assessment and how this changes during peanut desensitisation.


Information By: Imperial College London

Dates:
Date Received: May 24, 2014
Date Started: May 2015
Date Completion:
Last Updated: August 4, 2016
Last Verified: August 2016