search
Back to results

Immune and Clinical Implications of Threshold-based Phenotypes of Peanut Allergy (CAFETERIA)

Primary Purpose

Food Allergy, Peanut Allergy

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Peanut Protein
Sponsored by
Scott Sicherer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Food Allergy focused on measuring allergy, food, peanut, threshold, immunotherapy

Eligibility Criteria

4 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

-Subject and/or parent guardian must be able to understand and provide informed consent.

Inclusion criteria for screening DBPCFC:

  • Age 4-14 years
  • either sex
  • any race, any ethnicity
  • who are enrolled while strictly avoiding peanut
  • have a history of sensitization (detectable peanut IgE >0.35 kUA/L)

Inclusion criteria for randomization:

  • On screening DBPCFC are able to ingest >= 143 mg peanut protein but < 5043 mg peanut protein.
  • All children will have documented consent and assent as is appropriate for age.

Exclusion Criteria:

Individuals who meet any of these criteria are not eligible for enrollment as study participants:

  • Inability or unwillingness of a participant to give written informed consent or comply with study protocol
  • Serum peanut-specific IgE antibody level > 50 kUA/L
  • Recent (within the past 2 years) life-threatening (grade 3) anaphylactic reaction to peanut.
  • Any disorder in which epinephrine is contraindicated such as known hypertension or cardia rhythm disorders.
  • History of chronic disease requiring therapy (other than asthma, atopic dermatitis, rhinitis).
  • On a build-up phase of any allergen immunotherapy.
  • For those with a history of asthma, the following are assessed and any of the following is an exclusion (markers of current uncontrolled or moderate to severe asthma):

    1. FEV1 value <80% predicted (only for participants age 7 years or older and are able to perform spirometry
    2. ACT or cACT < 20
    3. >Step 3 controller therapy as defined for children 0-4, 5-11 and >=12 years of age by EPR-3 tables
    4. Use of steroid medications in the following manners:

      1. history of daily oral steroid dosing for >1 month during the past year,
      2. having 1 burst or steroid course within the past 6 months, or
      3. having >1 burst oral steroid course within the past 12 months.
    5. Asthma requiring >1 hospitalization in the past year for asthma or >1 ED visit in the past 6 months for asthma, or any prior intubation/mechanical ventilation for asthma/wheezing.
  • Gastrointestinal eosinophilic disorders, esophagitis, gastroenteritis.
  • Use of short-acting antihistamines (diphenhydramine, etc.) more than one time within 3 days prior to DBPCFC or skin testing.*
  • Use of medium-acting antihistamines (hydroxyzine, loratadine, etc.) more than one time within 7 days of DBPCFC or skin testing.*
  • Use of systemic steroid medications (IV, IM or oral) for indications other than asthma for > 3 weeks within the past 6 months
  • Use of beta-blockers (oral), (ACE) inhibitors, angiotensin-receptor blockers or calcium channel blockers.
  • Participation in any trials of therapeutic interventions for food allergy in the past year.
  • Therapy with anti-IgE or other biologics, including within 1 year of enrollment.
  • Use of investigational drugs within 52 weeks of participation.
  • Allergy to all of the following: oat, rice, corn, tapioca.
  • Pregnancy
  • Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

*Any subject meeting these criteria during the visits can be rescheduled for the oral food challenge or prick skin testing.*

Sites / Locations

  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Treatment

Avoidance

Arm Description

Ingests peanut - . Depending upon reaction threshold, participants may begin with different starting amounts of store bought peanut butter measured with study-supplied kitchen measuring spoons.

Avoids peanut, standard care

Outcomes

Primary Outcome Measures

The difference in the percentage of children that tolerate the full challenge
The difference in the percentage of children who by the endpoint DBPCFC tolerate a dose at least 2 steps higher than their baseline DBPCFC or 9043 mg of peanut protein as compared to baseline

Secondary Outcome Measures

The percentage of children that achieve sustained unresponsiveness
The percentage of children who achieve sustained unresponsiveness or natural tolerance during the study.
Number of acute allergic reactions
Safety parameter assessed by number of acute allergic reactions which includes anaphylaxis or gastrointestinal side effects.
Food Allergy Quality of Life Parental Burden Instrument
The Food Allergy Quality of Life-Parental Burden (FAQL-PB) Scale is a 17-item instrument. It utilizes a 7-point Likert scale ranging from 0 (not troubled) to 6 (extremely troubled). The number circled for each question is summed to provide a total continuous score with a higher score indicating greater burden on the family. Scores can range from 0 to 102 or can be divided by 17 to obtain a mean total score from 0 to 6.
Change in SPT wheal size
Change in Skin Prick Test (SPT) mean wheal size at 72 weeks as compared to baseline.
Change in Peanut-specific IgE
Changes in Peanut-specific IgE level at week 72 as compared to baseline.
Change in Peanut-specific IgG4
Changes in Peanut-specific IgG4 level at week 72 as compared to baseline.

Full Information

First Posted
April 5, 2019
Last Updated
March 7, 2023
Sponsor
Scott Sicherer
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
search

1. Study Identification

Unique Protocol Identification Number
NCT03907397
Brief Title
Immune and Clinical Implications of Threshold-based Phenotypes of Peanut Allergy
Acronym
CAFETERIA
Official Title
Challenging to Food With Escalating Thresholds for Reducing Food Allergy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 5, 2019 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Scott Sicherer
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this study is to determine whether allowing ingestion of sub-threshold amounts of peanut in those with a high threshold (tolerate at least 143 mg peanut protein on supervised double-blind, placebo-controlled oral food challenge [DBPCFC]) will be associated with attaining even higher thresholds over time in children with high threshold peanut allergy compared to those avoiding peanut. The secondary clinical objectives include assessing the development of sustained unresponsiveness (SU, a surrogate term for tolerance without daily ingestion), effects on quality of life, and safety compared to those avoiding peanut. Additionally, this study will phenotype the allergic response to peanut based on threshold and response to exposure. Mechanistic study objectives will determine the immune and molecular basis of the high threshold endotype, identify predictors of response to exposure, and determine mechanisms and biomarkers of remission.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Allergy, Peanut Allergy
Keywords
allergy, food, peanut, threshold, immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
200-250 children undergoing DBPCFC to peanut to identify 72 with high threshold peanut allergy for randomization in trial.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Active Comparator
Arm Description
Ingests peanut - . Depending upon reaction threshold, participants may begin with different starting amounts of store bought peanut butter measured with study-supplied kitchen measuring spoons.
Arm Title
Avoidance
Arm Type
No Intervention
Arm Description
Avoids peanut, standard care
Intervention Type
Biological
Intervention Name(s)
Peanut Protein
Intervention Description
up to 9043 mg
Primary Outcome Measure Information:
Title
The difference in the percentage of children that tolerate the full challenge
Description
The difference in the percentage of children who by the endpoint DBPCFC tolerate a dose at least 2 steps higher than their baseline DBPCFC or 9043 mg of peanut protein as compared to baseline
Time Frame
up to 72 weeks
Secondary Outcome Measure Information:
Title
The percentage of children that achieve sustained unresponsiveness
Description
The percentage of children who achieve sustained unresponsiveness or natural tolerance during the study.
Time Frame
up to 96 weeks
Title
Number of acute allergic reactions
Description
Safety parameter assessed by number of acute allergic reactions which includes anaphylaxis or gastrointestinal side effects.
Time Frame
up to 96 weeks
Title
Food Allergy Quality of Life Parental Burden Instrument
Description
The Food Allergy Quality of Life-Parental Burden (FAQL-PB) Scale is a 17-item instrument. It utilizes a 7-point Likert scale ranging from 0 (not troubled) to 6 (extremely troubled). The number circled for each question is summed to provide a total continuous score with a higher score indicating greater burden on the family. Scores can range from 0 to 102 or can be divided by 17 to obtain a mean total score from 0 to 6.
Time Frame
up to 72 weeks
Title
Change in SPT wheal size
Description
Change in Skin Prick Test (SPT) mean wheal size at 72 weeks as compared to baseline.
Time Frame
baseline and 72 weeks
Title
Change in Peanut-specific IgE
Description
Changes in Peanut-specific IgE level at week 72 as compared to baseline.
Time Frame
baseline and 72 weeks
Title
Change in Peanut-specific IgG4
Description
Changes in Peanut-specific IgG4 level at week 72 as compared to baseline.
Time Frame
baseline and 72 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: -Subject and/or parent guardian must be able to understand and provide informed consent. Inclusion criteria for screening DBPCFC: Age 4-14 years either sex any race, any ethnicity who are enrolled while strictly avoiding peanut have a history of sensitization (detectable peanut IgE >0.35 kUA/L) Inclusion criteria for randomization: On screening DBPCFC are able to ingest >= 143 mg peanut protein but < 5043 mg peanut protein. All children will have documented consent and assent as is appropriate for age. Exclusion Criteria: Individuals who meet any of these criteria are not eligible for enrollment as study participants: Inability or unwillingness of a participant to give written informed consent or comply with study protocol Serum peanut-specific IgE antibody level > 50 kUA/L Recent (within the past 2 years) life-threatening (grade 3) anaphylactic reaction to peanut. Any disorder in which epinephrine is contraindicated such as known hypertension or cardia rhythm disorders. History of chronic disease requiring therapy (other than asthma, atopic dermatitis, rhinitis). On a build-up phase of any allergen immunotherapy. For those with a history of asthma, the following are assessed and any of the following is an exclusion (markers of current uncontrolled or moderate to severe asthma): FEV1 value <80% predicted (only for participants age 7 years or older and are able to perform spirometry ACT or cACT < 20 >Step 3 controller therapy as defined for children 0-4, 5-11 and >=12 years of age by EPR-3 tables Use of steroid medications in the following manners: history of daily oral steroid dosing for >1 month during the past year, having 1 burst or steroid course within the past 6 months, or having >1 burst oral steroid course within the past 12 months. Asthma requiring >1 hospitalization in the past year for asthma or >1 ED visit in the past 6 months for asthma, or any prior intubation/mechanical ventilation for asthma/wheezing. Gastrointestinal eosinophilic disorders, esophagitis, gastroenteritis. Use of short-acting antihistamines (diphenhydramine, etc.) more than one time within 3 days prior to DBPCFC or skin testing.* Use of medium-acting antihistamines (hydroxyzine, loratadine, etc.) more than one time within 7 days of DBPCFC or skin testing.* Use of systemic steroid medications (IV, IM or oral) for indications other than asthma for > 3 weeks within the past 6 months Use of beta-blockers (oral), (ACE) inhibitors, angiotensin-receptor blockers or calcium channel blockers. Participation in any trials of therapeutic interventions for food allergy in the past year. Therapy with anti-IgE or other biologics, including within 1 year of enrollment. Use of investigational drugs within 52 weeks of participation. Allergy to all of the following: oat, rice, corn, tapioca. Pregnancy Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study. *Any subject meeting these criteria during the visits can be rescheduled for the oral food challenge or prick skin testing.*
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Sicherer, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Immune and Clinical Implications of Threshold-based Phenotypes of Peanut Allergy

We'll reach out to this number within 24 hrs