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Study of Tolerance to Oral Peanut

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01259804
Acronym
STOP
Enrollment
22
Registered
2010-12-14
Start date
2008-01-31
Completion date
2012-01-31
Last updated
2015-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peanut Allergy

Keywords

peanut, food allergy, anaphylaxis, immunotherapy

Brief summary

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

Detailed description

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.

Interventions

DIETARY_SUPPLEMENTPeanut oral immunotherapy

Daily doses of peanut flour

Sponsors

Cambridge University Hospitals NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* Peanut allergy defined by oral challenge

Exclusion criteria

* Major immunodeficiency

Design outcomes

Primary

MeasureTime frame
Pass/fail peanut challengesix months

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026