Study of Tolerance to Oral Peanut (STOP)
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|ClinicalTrials.gov Identifier: NCT01259804|
Recruitment Status : Completed
First Posted : December 14, 2010
Last Update Posted : January 14, 2015
|Condition or disease||Intervention/treatment||Phase|
|Peanut Allergy||Dietary Supplement: Peanut oral immunotherapy||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of High-dose Peanut Oral Immunotherapy With Factors Predicting Outcome|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
Experimental: Peanut immunotherapy
Dietary Supplement: Peanut oral immunotherapy
Daily doses of peanut flour
Other Name: Daily doses peanut flour
- Pass/fail peanut challenge [ Time Frame: six months ]
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
|Cambridge Biomedical Campus|
|Cambridge, Cambridgeshire, United Kingdom, CB23 7DS|
|Principal Investigator:||Andrew T Clark, MB BD MD||Cambridge Biomedical Campus|