Study of Tolerance to Oral Peanut (STOP)

NHS Foundation Trust

Status and phase: Completed; Phase 1

Conditions: Peanut Allergy

Treatments: Dietary Supplement: Peanut oral immunotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01259804

STOP-I

Details and patient eligibility

About

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

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Peanut allergy defined by oral challenge

Exclusion criteria

• Major immunodeficiency

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

22 participants in 1 patient group

Peanut immunotherapy

Experimental group

Description:

Peanut flour

Treatment:

Dietary Supplement: Peanut oral immunotherapy