Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
22 participants
INTERVENTIONAL
2008-01-31
2012-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Peanut immunotherapy
Peanut flour
Peanut oral immunotherapy
Daily doses of peanut flour
Interventions
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Peanut oral immunotherapy
Daily doses of peanut flour
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
7 Years
17 Years
ALL
No
Sponsors
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Cambridge University Hospitals NHS Foundation Trust
OTHER
Responsible Party
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Dr. Andrew Clark
Consultant
Principal Investigators
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Andrew T Clark, MB BD MD
Role: PRINCIPAL_INVESTIGATOR
Cambridge Biomedical Campus
Locations
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Cambridge Biomedical Campus
Cambridge, Cambridgeshire, United Kingdom
Countries
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References
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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.
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.
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.
Other Identifiers
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STOP-I
Identifier Type: -
Identifier Source: org_study_id
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