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OpenTrials
Completed

NCT Number: NCT01259804

Study of Tolerance to Oral Peanut

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

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Key information

Conditions

Peanut Allergy Anaphylaxis Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nut and Peanut Hypersensitivity Peanut Hypersensitivity

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cambridge Biomedical Campus

Cambridge, Cambridgeshire, CB23 7DS, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Peanut allergy defined by oral challenge

Exclusion criteria

  • Major immunodeficiency

Treatment and study plan

Peanut oral immunotherapy

Dietary Supplement

Daily doses of peanut flour

Other names: Daily doses peanut flour

Primary outcomes

  1. Pass/fail peanut challenge

    Time frame: six months

Sponsors and collaborators

Lead sponsor

Cambridge University Hospitals NHS Foundation Trust

Other

Registry information

Official study title

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

Acronym: STOP

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Dec 14, 2010
Registry last updated
Jan 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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