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Study of Tolerance to Oral Peanut (STOP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Cambridge University Hospitals NHS Foundation Trust.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01259804
First received: December 13, 2010
Last updated: September 9, 2011
Last verified: July 2010
History of Changes
  Purpose

Open pilot study of peanut oral immunotherapy in 22 children with peanut allergy


Condition Intervention Phase
Peanut Allergy
 Dietary Supplement: Peanut oral immunotherapy
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of High-dose Peanut Oral Immunotherapy With Factors Predicting Outcome

Resource links provided by NLM:

MedlinePlus related topics: Allergy
U.S. FDA Resources

Further study details as provided by Cambridge University Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • Pass/fail peanut challenge [ Time Frame: six months ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: January 2008
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Peanut immunotherapy
Peanut flour
 Dietary Supplement: Peanut oral immunotherapy
Daily doses of peanut flour
Other Name: Daily doses peanut flour

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.

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Peanut allergy defined by oral challenge

Exclusion Criteria:

  • Major immunodeficiency
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01259804

Locations
United Kingdom
Cambridge Biomedical Campus
Cambridge, Cambridgeshire, United Kingdom, CB23 7DS
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Andrew T Clark, MB BD MD Cambridge Biomedical Campus
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Mr Stephen Kelliher, Head of R and D, Cambridge University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01259804     History of Changes
Other Study ID Numbers: STOP-I
Study First Received: December 13, 2010
Last Updated: September 9, 2011
Health Authority: United Kingdom: National Health Service

Keywords provided by Cambridge University Hospitals NHS Foundation Trust:
peanut
food allergy
anaphylaxis
immunotherapy

Additional relevant MeSH terms:
Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on May 23, 2013