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
|Condition or disease||Intervention/treatment||Phase|
|Food Allergy Peanut Allergy||Biological: Peanut Protein||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||98 participants|
|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)|
|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|
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
- 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
- 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.
- 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.
- 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.
- 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.
- Change in Peanut-specific IgE [ Time Frame: baseline and 72 weeks ]Changes in Peanut-specific IgE level at week 72 as compared to baseline.
- Change in Peanut-specific IgG4 [ Time Frame: baseline and 72 weeks ]Changes in Peanut-specific IgG4 level at week 72 as compared to baseline.
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
|Contact: Scott H Sicherer, MDfirstname.lastname@example.org|
|Contact: Julie Wang, MDemail@example.com|
|United States, New York|
|Icahn School of Medicine at Mount Sinai||Not yet recruiting|
|New York, New York, United States, 10029|
|Principal Investigator:||Scott Sicherer, MD||Icahn School of Medicine at Mount Sinai|