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Study of Tolerance to Oral Peanut (STOP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01259804
First Posted: December 14, 2010
Last Update Posted: January 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Andrew Clark, Cambridge University Hospitals NHS Foundation Trust
  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: Intervention Model: Single Group Assignment
Masking: None (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 Dr. Andrew Clark, 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.

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Peanut allergy defined by oral challenge

Exclusion Criteria:

  • Major immunodeficiency
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Andrew Clark, Consultant, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01259804     History of Changes
Other Study ID Numbers: STOP-I
First Submitted: December 13, 2010
First Posted: December 14, 2010
Last Update Posted: January 14, 2015
Last Verified: January 2015

Keywords provided by Dr. Andrew Clark, Cambridge University Hospitals NHS Foundation Trust:
peanut
food allergy
anaphylaxis
immunotherapy

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