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Study of Tolerance to Oral Peanut (STOP)

Primary Purpose

Peanut Allergy

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Peanut oral immunotherapy
Sponsored by
Cambridge University Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peanut Allergy focused on measuring peanut, food allergy, anaphylaxis, immunotherapy

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Peanut allergy defined by oral challenge

Exclusion Criteria:

  • Major immunodeficiency

Sites / Locations

  • Cambridge Biomedical Campus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Peanut immunotherapy

Arm Description

Peanut flour

Outcomes

Primary Outcome Measures

Pass/fail peanut challenge

Secondary Outcome Measures

Full Information

First Posted
December 13, 2010
Last Updated
January 13, 2015
Sponsor
Cambridge University Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01259804
Brief Title
Study of Tolerance to Oral Peanut
Acronym
STOP
Official Title
Efficacy and Safety of High-dose Peanut Oral Immunotherapy With Factors Predicting Outcome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cambridge University Hospitals NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Open pilot study of peanut oral immunotherapy in 22 children with peanut allergy
Detailed Description
Background Peanut allergy is severe and rarely resolves. Objective To test the efficacy and safety of a new oral immunotherapy protocol for peanut allergy. Method 22 peanut-allergic children will undergo oral challenge. Oral immunotherapy will be administered by gradual updosing with 2-weekly increments (8-38w) to 800mg protein (5 peanuts/day) followed by 30-weeks maintenance. Oral challenge will be repeated after 6 and 30 weeks maintenance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peanut Allergy
Keywords
peanut, food allergy, anaphylaxis, immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peanut immunotherapy
Arm Type
Experimental
Arm Description
Peanut flour
Intervention Type
Dietary Supplement
Intervention Name(s)
Peanut oral immunotherapy
Other Intervention Name(s)
Daily doses peanut flour
Intervention Description
Daily doses of peanut flour
Primary Outcome Measure Information:
Title
Pass/fail peanut challenge
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Peanut allergy defined by oral challenge Exclusion Criteria: Major immunodeficiency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew T Clark, MB BD MD
Organizational Affiliation
Cambridge Biomedical Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cambridge Biomedical Campus
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB23 7DS
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19226304
Citation
Clark AT, Islam S, King Y, Deighton J, Anagnostou K, Ewan PW. Successful oral tolerance induction in severe peanut allergy. Allergy. 2009 Aug;64(8):1218-20. doi: 10.1111/j.1398-9995.2009.01982.x. Epub 2009 Feb 17.
Results Reference
result
PubMed Identifier
31676085
Citation
Santos AF, James LK, Kwok M, McKendry RT, Anagnostou K, Clark AT, Lack G. Peanut oral immunotherapy induces blocking antibodies but does not change the functional characteristics of peanut-specific IgE. J Allergy Clin Immunol. 2020 Jan;145(1):440-443.e5. doi: 10.1016/j.jaci.2019.09.005. Epub 2019 Oct 30. No abstract available.
Results Reference
derived
PubMed Identifier
21414048
Citation
Anagnostou K, Clark A, King Y, Islam S, Deighton J, Ewan P. Efficacy and safety of high-dose peanut oral immunotherapy with factors predicting outcome. Clin Exp Allergy. 2011 Sep;41(9):1273-81. doi: 10.1111/j.1365-2222.2011.03699.x. Epub 2011 Mar 18.
Results Reference
derived

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Study of Tolerance to Oral Peanut

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