Study of Tolerance to Oral Peanut

NCT ID: NCT01259804

Last Updated: 2015-01-14

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2012-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Peanut Allergy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Peanut immunotherapy

Peanut flour

Group Type EXPERIMENTAL

Peanut oral immunotherapy

Intervention Type DIETARY_SUPPLEMENT

Daily doses of peanut flour

Interventions

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Peanut oral immunotherapy

Daily doses of peanut flour

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Daily doses peanut flour

Eligibility Criteria

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Inclusion Criteria

* Peanut allergy defined by oral challenge

Exclusion Criteria

* Major immunodeficiency
Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Dr. Andrew Clark

Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United Kingdom

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.

Reference Type RESULT
PMID: 19226304 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31676085 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21414048 (View on PubMed)

Other Identifiers

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STOP-I

Identifier Type: -

Identifier Source: org_study_id

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