Study of Tolerance to Oral Peanut (STOP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Cambridge University Hospitals NHS Foundation Trust.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01259804
First received: December 13, 2010
Last updated: September 9, 2011
Last verified: July 2010

December 13, 2010
September 9, 2011
January 2008
January 2012   (final data collection date for primary outcome measure)
Pass/fail peanut challenge [ Time Frame: six months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01259804 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of Tolerance to Oral Peanut
Efficacy and Safety of High-dose Peanut Oral Immunotherapy With Factors Predicting Outcome

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

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Peanut Allergy
Dietary Supplement: Peanut oral immunotherapy
Daily doses of peanut flour
Other Name: Daily doses peanut flour
Experimental: Peanut immunotherapy
Peanut flour
Intervention: Dietary Supplement: Peanut oral immunotherapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
22
January 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Peanut allergy defined by oral challenge

Exclusion Criteria:

  • Major immunodeficiency
Both
7 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01259804
STOP-I
No
Mr Stephen Kelliher, Head of R and D, Cambridge University Hospitals NHS Trust
Cambridge University Hospitals NHS Foundation Trust
Not Provided
Principal Investigator: Andrew T Clark, MB BD MD Cambridge Biomedical Campus
Cambridge University Hospitals NHS Foundation Trust
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP