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NCT01259804 Clinical Trial

Study of Tolerance to Oral Peanut

Peanut Allergy Clinical Trial

— STOP  

Official title:
Efficacy and Safety of High-dose Peanut Oral Immunotherapy With Factors Predicting Outcome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01259804
Other study ID # STOP-I
Secondary ID
Status Completed
Phase Phase 1
First received December 13, 2010
Last updated January 13, 2015
Start date January 2008
Est. completion date January 2012

Study information
Verified date January 2015
Source Cambridge University Hospitals NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date January 2012
Est. primary completion date January 2012
Accepts healthy volunteers No
Gender Both
Age group 7 Years to 17 Years
Eligibility Inclusion Criteria:

- Peanut allergy defined by oral challenge

Exclusion Criteria:

- Major immunodeficiency

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Peanut oral immunotherapy
Daily doses of peanut flour

Locations
Country Name City State
United Kingdom Cambridge Biomedical Campus Cambridge Cambridgeshire

Sponsors (1)
Lead Sponsor Collaborator
Cambridge University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Pass/fail peanut challenge six months No
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