Text Size

Persistence of Oral Tolerance to Peanut (LEAP-On)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01366846
First received: June 2, 2011
Last updated: January 8, 2013
Last verified: January 2013
History of Changes
  Purpose

ITN049AD (LEAP-On) Study is a continuation of the ITN032AD LEAP Study (NCT00329784).

Peanut Allergy, a recognized public health concern, is a common and potentially life-threatening food allergy for which there is no treatment. ITN032AD (LEAP) Study evaluated whether early exposure to peanut promotes tolerance and provides protection from developing peanut allergy in children who are allergic to eggs or who have severe eczema. ITN049AD (LEAP-On) Study will evaluate persistent tolerance to peanut by assessing the effect of twelve months of cessation of peanut consumption in LEAP Study participants who consumed peanut and those who avoided peanut over the previous five years.


Condition Intervention Phase
Eczema
Egg Allergy
Food Allergy
Hypersensitivity
 Other: Avoidance of peanut
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Persistence of Oral Tolerance Induction to Peanut and Its Immunological Basis (LEAP-On) (ITN049AD)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Proportion of participants with peanut allergy in the peanut avoidance after continuous peanut consumption group and the continued peanut avoidance group [ Time Frame: Year 6 ] [ Designated as safety issue: Yes ]
    Comparison of the proportion of peanut allergy between both groups will be made allowing for the evaluation of whether the early consumption of peanut induces a state of 'persistent tolerance'.


Secondary Outcome Measures:
  • Proportion of participants with peanut allergy in the peanut avoidance after continuous peanut consumption group [ Time Frame: Year 6 ] [ Designated as safety issue: Yes ]
    The within group comparison in peanut avoidance after continuous peanut consumption between year 5 and year 6 will allow the identification and statistical evaluation of a group of children with 'transient desensitisation'.

  • Proportion of subjects with allergic sensitization to selected ingested and inhaled allergens, and with seasonal rhino-conjunctivitis, perennial rhinoconjunctivitis, and asthma. [ Time Frame: Year 6 ] [ Designated as safety issue: No ]
  • Incidence of adverse events, and nutritional evaluations. [ Time Frame: Year 6 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 635
Study Start Date: December 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Peanut avoidance after continous peanut consumption
These participants were the peanut consumption group of the ITN032AD (LEAP) study
 Other: Avoidance of peanut
All participants will be assigned to peanut avoidance as per United Kingdom (UK) public health recommendations and will avoid exposure to peanut protein during the study until the last study visit when they will receive the Oral Food Challenge.
Experimental: Continued peanut avoidance
These participants were the peanut avoidance group of the ITN032AD (LEAP) study
 Other: Avoidance of peanut
All participants will be assigned to peanut avoidance as per United Kingdom (UK) public health recommendations and will avoid exposure to peanut protein during the study until the last study visit when they will receive the Oral Food Challenge.

  Eligibility

Ages Eligible for Study:   5 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All LEAP Study participants who are evaluable for peanut allergy at year 5 by LEAP Study criteria.
  • Parent or guardian willing to provide informed consent.

Exclusion Criteria:

  • Unable or unwilling to comply with study intervention and procedures.
  • Participation in other food allergy intervention trials.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01366846

Locations
United Kingdom
Evelina Children's Hospital
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network (ITN)
Investigators
Study Chair: Gideon Lack, MD Evelina Children's Hospital
  More Information

Additional Information:
LEAP Study informational website  This link exits the ClinicalTrials.gov site
Immune Tolerance Network  This link exits the ClinicalTrials.gov site
National Institute of Allergy and Infectious Diseases (NIAID)  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01366846     History of Changes
Other Study ID Numbers: DAIT ITN049AD
Study First Received: June 2, 2011
Last Updated: January 8, 2013
Health Authority: United States: Federal Government
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Peanut

Additional relevant MeSH terms:
Hypersensitivity
Eczema
Food Hypersensitivity
Egg Hypersensitivity
Immune System Diseases
 Dermatitis
Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on May 23, 2013