NCT01429896

Brief Summary

Food allergy is a common problem, affecting 5-8% of the population. Peanut allergy causes reduced quality of life due to the perceived high risk of severe reactions. Patients rely on accurate labeling of both loose and pre-packed foods, but these are often ambiguous and unhelpful. There is a common conception that labeling is 'over-cautious'. Peanut-allergic consumers face increasingly restricted food choices in complying with this advice due, in part, to the proliferation of advisory labels such as 'may contain peanuts'. This contributes to the reduces quality of life of affected individuals. For industry to provide more accurate and helpful labeling, certain characteristics of the food-allergic population need to be defined. Firstly, the minimum 'eliciting dose' for the population has been estimated by studying large groups of peanut allergic patients who are challenged with peanut ingestion in increasing amounts. From these, an eliciting dose that provokes a reaction in 10% of the food-allergic population has been estimated at between six and 14mg of peanut protein. Translation of population eliciting doses (ED) into acceptable levels of allergen contamination for the population requires consideration of a 'safety factor'- to account for individual variability in dose threshold and severity. Data suggest such variability depends in part on extrinsic factors (exercise and sleep restriction). Each factor may have a different effect in scale and direction. The investigators are proposing a cross-over trial with 85 peanut-allergic adults who will each undergoing a baseline peanut challenge followed by repeat challenges with extrinsic factors applied, in random order (repeat baseline, +exercise and +sleep restriction). These data will further define ED for the UK population and a safety factor derived from shift in threshold, to inform industry and protect the allergic population.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2012

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 7, 2011

Completed
1.1 years until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

January 14, 2015

Status Verified

January 1, 2015

Enrollment Period

2.9 years

First QC Date

August 31, 2011

Last Update Submit

January 13, 2015

Conditions

Peanut Hypersensitivity

Keywords

peanut allergyfood allergythresholdsanaphylaxisfood labellingfood challengespeanut challenges

Outcome Measures

Primary Outcomes (1)

  • minimum amount of peanut protein in milligrams which causes an objective clinical reaction during peanut challenges

    36 months

Study Arms (6)

Arm 1

EXPERIMENTAL

Exercise followed by sleep restriction followed by control challenge

Other: Food challenge

Arm 2

EXPERIMENTAL

Sleep restriction followed by exercise followed by control challenge

Other: Food challenge

Arm 3

EXPERIMENTAL

control followed by sleep restriction followed by exercise

Other: Food challenge

Arm 4

EXPERIMENTAL

control followed by exercise followed by sleep restriction

Other: Food challenge

Arm 5

EXPERIMENTAL

Sleep Restriction followed by control followed by exercise

Other: Food challenge

Arm 6

EXPERIMENTAL

Exercise followed by control followed by sleep restriction

Other: Food challenge

Interventions

Food challengeOTHER

Double blind placebo controlled peanut challenge. Each challenge given with or without extrinsic factors exercise or sleep restriction.

Also known as: Threshold extrinsic factor challenges
Arm 1Arm 2Arm 3Arm 4Arm 5Arm 6

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Written informed consent must be obtained before any assessment is performed.
  • Male and female subject who are 18-45 years of age at the time of study entry (Visit 1) who have a diagnosis of acute peanut allergy as manifested by urticaria, angioedema or respiratory/gastrointestinal tract symptoms, with acute onset of symptoms after ingestion (up to 2h).
  • A positive peanut DBPCFC at baseline (Visit 1). This outcome is defined as the onset of objective allergic events after ingestion of peanut protein but not to the placebo. Eligibility to the DBPCFC requires fulfillment of all other eligibility criteria at visit 1.
  • Subjects must be able to comply with the study procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Addenbrooke's Hospital

Cambridge, Cambs, CB2 2QQ, United Kingdom

RECRUITING

Imperial College

London, London, W2 1PG, United Kingdom

RECRUITING

Related Publications (2)

  • Avery NJ, King RM, Knight S, Hourihane JO. Assessment of quality of life in children with peanut allergy. Pediatr Allergy Immunol. 2003 Oct;14(5):378-82. doi: 10.1034/j.1399-3038.2003.00072.x.

    PMID: 14641608BACKGROUND

  • Dua S, Ruiz-Garcia M, Bond S, Durham SR, Kimber I, Mills C, Roberts G, Skypala I, Wason J, Ewan P, Boyle R, Clark A. Effect of sleep deprivation and exercise on reaction threshold in adults with peanut allergy: A randomized controlled study. J Allergy Clin Immunol. 2019 Dec;144(6):1584-1594.e2. doi: 10.1016/j.jaci.2019.06.038. Epub 2019 Jul 15.

    PMID: 31319102DERIVED

MeSH Terms

Conditions

Peanut HypersensitivityFood HypersensitivityAnaphylaxis

Condition Hierarchy (Ancestors)

Nut and Peanut HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Andrew T Clark, MB BS MD

    Cambridge University Hospitals NHS Trust

    STUDY DIRECTOR

Central Study Contacts

Andrew T Clark, MB BS MD

CONTACT

+44 1223 762603andrew.clark@addenbrookes.nhs.uk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Lecturer and Consultant in Paediatric Allergy

Study Record Dates

First Submitted

August 31, 2011

First Posted

September 7, 2011

Study Start

October 1, 2012

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

January 14, 2015

Record last verified: 2015-01

Locations

GB(2)