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Peanut Oral Immunotherapy in Children With Peanut Allergy (PeanutFlour)

Primary Purpose

Peanut Allergic Subjects

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Peanut Oral Immunotherapy (POIT)

About this trial

This is an interventional treatment trial for Peanut Allergic Subjects focused on measuring Peanut Allergy, Anaphylaxis, Desensitization, Food Allergy, Oral Immunotherapy

Eligibility Criteria

5 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 5-16 years of either sex, any race, any ethnicity, weighing at least 18.3 kg at the time of the initial visit.
The presence of Immunoglobulin E (IgE) specific to peanuts (a positive skin prick test to peanuts (diameter of wheal > 3.0 mm) and a positive in vitro IgE [CAP-FEIA] > 7 kUA/L) measured within the past year.
Significant clinical symptoms occurring within 120 minutes after ingesting peanuts during an observed DBPCFC. Patients who have not had previous oral exposure to peanut will be observed for a longer duration of 150 minutes because they may demonstrate a delayed immune response, given the lack of prior peanut exposure. Also, patients with a history of prior anaphylaxis will be observed for 150 minutes.
Provide signed informed consent.
Ability to follow-up regularly for scheduled appointments.
Subjects will not be excluded if they are primarily Spanish speaking.
Females of childbearing potential must be willing to practice an acceptable form of birth control throughout the protocol.
Epinephrine injection training provided. Participant has current in-date epinephrine injector and parent/guardian demonstrates proper use

Exclusion Criteria:

History of severe anaphylaxis to peanut as defined by hypoxia, hypotension, or neurological compromise (Cyanosis or SpO2 < 92% at any stage, hypotension, confusion, collapse, loss of consciousness; or incontinence)
Currently participating in a study using an investigational new drug.
Participation in any interventional study for the treatment of food allergy in the past 12 months or while participating in this study.
Poor control or persistent activation of atopic dermatitis.
Diagnosis of persistent asthma as defined by NHLBI criteria and currently being treated with daily doses of inhaled corticosteroids or requiring a rescue inhaler more than 2 days per week.
Inability to discontinue antihistamines for skin testing and Oral Food Challenges (OFCs).
Pregnant female.
Chronic medical condition requiring frequent use of oral steroids, chronic psychiatric illness or history of substance abuse.
Active eosinophilic esophagitis requiring medication therapy during the past 12 months.
Subjects with known oat or wheat allergy
Subjects currently on the build-up phase of environmental allergy immunotherapy injections
Live more than 175 miles away from Texas Children's Hospital located in the Medical Center.

Sites / Locations

Texas Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Peanut Oral Immunotherapy (POIT)

Arm Description

The peanut OIT is taken in the form of peanut flour. It will be given in small cups containing the amount of flour that needs to be eaten for one dose. One dose should be taken per day.

Outcomes

Primary Outcome Measures

Safety and Efficacy

Determine whether peanut oral immunotherapy safely develops clinical tolerance in peanut allergic subjects by assessing the change of dose tolerated and to determine the percentage of subjects who can tolerate 6 g of peanut flour with absence of clinical symptoms during a food challenge following the initial desensitization phase of peanut flour

Secondary Outcome Measures

Immune Response

To determine the immune mechanisms of clinical tolerance, using technology to identify T cell cytokine responses and subsets, as well as basophil activation responses as measured by flow cytometry. T and NKT cell function and intracellular cytokine expression will be measured.

Viral Exposure

To determine whether viral exposure potentiates response to in vitro peanut allergen exposure and to assess those changes during peanut OIT.

Dose Toleration

To compare the change in dose tolerated after one month of abstaining from peanut to determine sustained unresponsiveness.

Full Information

NCT ID

NCT02203799

First Posted

July 28, 2014

Last Updated

July 20, 2020

Sponsor

Baylor College of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT02203799

Brief Title

Peanut Oral Immunotherapy in Children With Peanut Allergy

Acronym

PeanutFlour

Official Title

Immune Responses in Peanut Allergic Subjects Undergoing Peanut Oral Immunotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

July 31, 2014 (Actual)

Primary Completion Date

February 11, 2020 (Actual)

Study Completion Date

February 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Baylor College of Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Many children who are allergic to peanuts do not outgrow their allergy and have very severe allergic reactions called anaphylaxis. Symptoms of anaphylaxis include difficulty breathing, decreased blood pressure, hives, and lip or throat swelling after exposure to an allergen. A severe allergic reaction can lead to death if not treated appropriately. The purpose of this study is to find out if there is a way to treat children with peanut allergy to help lower the risk of severe allergic reactions and also cause them to lose their allergy to peanuts. The approach that will used for this study is a process called "desensitization". Oral immunotherapy involves eating gradually increasing amounts of a food over several months. This is a research study because at this time peanut oral immunotherapy (OIT) is investigational. Peanut OIT (study drug) is investigational because it is not currently approved for clinical use by the Food and Drug Administration. There are no alternative safe and effective treatments for peanut induced allergic reactions other than peanut avoidance and treatment with medications.

Detailed Description

This is a phase I, open label study for the initial 12 month desensitization phase of peanut oral immunotherapy and a 2 year maintenance phase. Subjects will be recruited to determine the immune response during the administration of peanut OIT after the development of disease. Cohort will include children age 5-16 years who have peanut allergy. The study will require approximately 36 visits with 3 phases: screening phase (~ 2 months); build-up phase (weeks 1 year), followed by the maintenance phase (2 years). The primary objective of the OIT protocol is to desensitize subjects to peanut and this occurs over the first 12 months of the study (build-up phase). The first dose will be based on the amount at which the subject reacted during a double blind placebo controlled food challenge (DBPCFC). Thereafter, dose escalation would continue as outlined in the protocol for approximately 50 weeks until the maintenance dose of peanut protein (3900 mg) is reached. The maintenance phase will continue from the end of the build-up phase until approximately 24 months. During this phase, the subject will switch to a peanut equivalent dose for the maintenance phase. At the conclusion of the maintenance phase a DBPCFC will be done. Negative challenges will be confirmed by open challenge. DBPCFC will be done.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peanut Allergic Subjects

Keywords

Peanut Allergy, Anaphylaxis, Desensitization, Food Allergy, Oral Immunotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Peanut Oral Immunotherapy (POIT)

Arm Type

Experimental

Arm Description

The peanut OIT is taken in the form of peanut flour. It will be given in small cups containing the amount of flour that needs to be eaten for one dose. One dose should be taken per day.

Intervention Type

Biological

Intervention Name(s)

Peanut Oral Immunotherapy (POIT)

Other Intervention Name(s)

Peanut Flour, Peanut Oral Immunotherapy

Intervention Description

The peanut protein is ingested in the form of peanut flour. Peanut flour will be given in small pre-measured soufflé cups containing the amount of peanut flour that needs to be eaten for one dose. One dose will be taken per day. Dosage of the peanut flour will begin with 1.8 mg of peanut protein during the initial visit or the lowest tolerated dose on initial challenge and increased every 2 during the build-up phase until the maintenance dose of peanut protein (3900 mg) is reached.

Primary Outcome Measure Information:

Title

Safety and Efficacy

Description

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Immune Response

Description

Time Frame

3 years

Title

Viral Exposure

Description

To determine whether viral exposure potentiates response to in vitro peanut allergen exposure and to assess those changes during peanut OIT.

Time Frame

3 years

Title

Dose Toleration

Description

To compare the change in dose tolerated after one month of abstaining from peanut to determine sustained unresponsiveness.

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 5-16 years of either sex, any race, any ethnicity, weighing at least 18.3 kg at the time of the initial visit. The presence of Immunoglobulin E (IgE) specific to peanuts (a positive skin prick test to peanuts (diameter of wheal > 3.0 mm) and a positive in vitro IgE [CAP-FEIA] > 7 kUA/L) measured within the past year. Significant clinical symptoms occurring within 120 minutes after ingesting peanuts during an observed DBPCFC. Patients who have not had previous oral exposure to peanut will be observed for a longer duration of 150 minutes because they may demonstrate a delayed immune response, given the lack of prior peanut exposure. Also, patients with a history of prior anaphylaxis will be observed for 150 minutes. Provide signed informed consent. Ability to follow-up regularly for scheduled appointments. Subjects will not be excluded if they are primarily Spanish speaking. Females of childbearing potential must be willing to practice an acceptable form of birth control throughout the protocol. Epinephrine injection training provided. Participant has current in-date epinephrine injector and parent/guardian demonstrates proper use Exclusion Criteria: History of severe anaphylaxis to peanut as defined by hypoxia, hypotension, or neurological compromise (Cyanosis or SpO2 < 92% at any stage, hypotension, confusion, collapse, loss of consciousness; or incontinence) Currently participating in a study using an investigational new drug. Participation in any interventional study for the treatment of food allergy in the past 12 months or while participating in this study. Poor control or persistent activation of atopic dermatitis. Diagnosis of persistent asthma as defined by NHLBI criteria and currently being treated with daily doses of inhaled corticosteroids or requiring a rescue inhaler more than 2 days per week. Inability to discontinue antihistamines for skin testing and Oral Food Challenges (OFCs). Pregnant female. Chronic medical condition requiring frequent use of oral steroids, chronic psychiatric illness or history of substance abuse. Active eosinophilic esophagitis requiring medication therapy during the past 12 months. Subjects with known oat or wheat allergy Subjects currently on the build-up phase of environmental allergy immunotherapy injections Live more than 175 miles away from Texas Children's Hospital located in the Medical Center.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carla M Davis, MD

Organizational Affiliation

Texas Children's Hospital/Baylor College of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Texas Children's Hospital

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

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Peanut Oral Immunotherapy in Children With Peanut Allergy

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