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Trial record 59 of 340 for:    "Food Allergy"

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

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ClinicalTrials.gov Identifier: NCT03907397
Recruitment Status : Not yet recruiting
First Posted : April 9, 2019
Last Update Posted : June 14, 2019
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Scott Sicherer, Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Food Allergy Peanut Allergy Biological: Peanut Protein Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 200-250 children undergoing DBPCFC to peanut to identify 98 with high threshold peanut allergy for randomization in trial.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Challenging to Food With Escalating Thresholds for Reducing Food Allergy
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Treatment
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.
Biological: Peanut Protein
up to 9043 mg

No Intervention: Avoidance
Avoids peanut, standard care



Primary Outcome Measures :
  1. The difference in the percentage of children that tolerate the full challenge [ Time Frame: up to 72 weeks ]
    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 :
  1. The percentage of children that achieve sustained unresponsiveness [ Time Frame: up to 96 weeks ]
    The percentage of children who achieve sustained unresponsiveness or natural tolerance during the study.

  2. Number of acute allergic reactions [ Time Frame: up to 96 weeks ]
    Safety parameter assessed by number of acute allergic reactions which includes anaphylaxis or gastrointestinal side effects.

  3. Food Allergy Quality of Life Parental Burden Instrument [ Time Frame: up to 72 weeks ]
    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.

  4. Change in SPT wheal size [ Time Frame: baseline and 72 weeks ]
    Change in Skin Prick Test (SPT) mean wheal size at 72 weeks as compared to baseline.

  5. Change in Peanut-specific IgE [ Time Frame: baseline and 72 weeks ]
    Changes in Peanut-specific IgE level at week 72 as compared to baseline.

  6. Change in Peanut-specific IgG4 [ Time Frame: baseline and 72 weeks ]
    Changes in Peanut-specific IgG4 level at week 72 as compared to baseline.



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • Current uncontrolled or moderate to severe asthma as defined by at least one of the following:

    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.*


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03907397


Contacts
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Contact: Scott H Sicherer, MD 212-241-5548 scott.sicherer@mssm.edu
Contact: Julie Wang, MD 212-241-5548 julie.wang@mssm.edu

Locations
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United States, New York
Icahn School of Medicine at Mount Sinai Not yet recruiting
New York, New York, United States, 10029
Sponsors and Collaborators
Scott Sicherer
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Scott Sicherer, MD Icahn School of Medicine at Mount Sinai

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Responsible Party: Scott Sicherer, Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03907397     History of Changes
Other Study ID Numbers: GCO 17-0722
U19AI136053 ( U.S. NIH Grant/Contract )
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Scott Sicherer, Icahn School of Medicine at Mount Sinai:
allergy
food
peanut
threshold
immunotherapy

Additional relevant MeSH terms:
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Hypersensitivity
Food Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate
Nut and Peanut Hypersensitivity