Completed

PnOIT4Peanut Protein Dosing for Desensitization in Peanut Allergic Children

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Study Aim

This study aims to evaluate the percentage of peanut allergic children who can develop desensitization and consume 5000mg of peanut protein after completing a build-up phase of peanut OIT.

What is being tested

Peanut Allergy Oral Treatment

Drug
Who is being recruted

Nut and Peanut Hypersensitivity+3

+ Hypersensitivity

+ Hypersensitivity, Immediate

From 4 to 12 Years
+21 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Phase 2
Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorUniversity of North Carolina, Chapel Hill
Last updated: March 1, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

Peanut allergic children will undergo an oral food challenge (OFC) to 1 gm peanut protein in order to accomplish two objectives: (1)to confirm the diagnosis of peanut allergy, and (2) to measure the amount of peanut protein it takes to cause an allergic reaction. Each subject will then undergo a modified rush phase in which the subject receives 6 doses of peanut protein in one day. The build-up phase begins afterward in which the subject's dose of peanut protein is increased every 2 weeks for 36 weeks. After the final build-up dose, the subject consumes that dose for 2 weeks after which he or she returns to the food allergy center for the second food challenge. If the subject successfully consumes this food challenge without symptoms, the daily dosing of peanut protein will be stopped and the subject will then undergo a third food challenge. If the subject successfully consumes the peanut protein during that challenge, he or she will return for a fourth food challenge to peanut.

NCT01814241
Principal SponsorUniversity of North Carolina, Chapel Hill
Last updated: March 1, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 4 to 12 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Nut and Peanut HypersensitivityHypersensitivityHypersensitivity, ImmediateImmune System DiseasesFood HypersensitivityPeanut Hypersensitivity

Criteria

8 inclusion criteria required to participate
Age 4 to up to 12 years of age of any gender, race, or ethnicity

Allergic reaction to <= 1 gm peanut protein during a blinded oral challenge test conducted at screening (e.g., a double-blinded, placebo-controlled food challenge [DBPCFC])

Consumption of oat-containing product within 90 days prior to enrollment

Detectable serum peanut -specific IgE level (CAP-FEIA >= 0.35 kU/L) and a positive SPT (wheal >= 3mm on skin prick test to peanut extract compared to a negative control.)

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13 exclusion criteria prevent from participating
Active eosinophilic gastrointestinal disease in the past 2 years

Any systemic therapy which in the judgment of the investigator could be immunomodulatory (e.g. rituximab) in the 12 months prior to visit -1, Systemic corticosteroid therapy of up to a total of three weeks is allowed

Asthma defined as moderate or severe persistent by National Asthma Education and Prevention Program Expert Panel Guidelines (e.g. asthma that requires more than fluticasone 440 mcg or its equivalent daily for adequate control)

Chronic disease other than asthma, atopic dermatitis, rhinitis requiring therapy; e.g., heart disease or diabetes

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Open label orally ingested peanut flour with maintenance dose of 1450mg

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

UNC Chapel Hill

Chapel Hill, United StatesOpen UNC Chapel Hill in Google Maps
CompletedOne Study Center