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Study of Tolerance to Oral Peanut (STOP)

This study has been completed.
Information provided by (Responsible Party):
Dr. Andrew Clark, Cambridge University Hospitals NHS Foundation Trust Identifier:
First received: December 13, 2010
Last updated: January 13, 2015
Last verified: January 2015
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: 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:

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

Primary Outcome Measures:
  • Pass/fail peanut challenge [ Time Frame: six months ]

Enrollment: 22
Study Start Date: January 2008
Study Completion Date: January 2012
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.


Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Peanut allergy defined by oral challenge

Exclusion Criteria:

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

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Andrew Clark, Consultant, Cambridge University Hospitals NHS Foundation Trust Identifier: NCT01259804     History of Changes
Other Study ID Numbers: STOP-I
Study First Received: December 13, 2010
Last Updated: January 13, 2015

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

Additional relevant MeSH terms:
Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases processed this record on May 23, 2017