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Allergen-Specific Immunotherapy

Peanut Protein for Peanut Allergy (CAFETERIA Trial)

Phase 2
Waitlist Available
Led By Scott Sicherer, MD
Research Sponsored by Scott Sicherer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 96 weeks
Awards & highlights

CAFETERIA Trial Summary

This trial is testing whether kids with a high threshold for peanut allergies can eat small amounts of peanuts to build up a tolerance, and if this changes their quality of life.

Who is the study for?
This trial is for children aged 4-14 with a history of peanut allergy who can tolerate a small amount of peanut protein (at least 143 mg but less than 5043 mg). They must be avoiding peanuts and have no severe allergic reactions or chronic diseases requiring therapy, except controlled asthma. Participants cannot have used certain medications or been in other food allergy trials within the past year.Check my eligibility
What is being tested?
The study tests if consuming tiny amounts of peanut can increase tolerance over time in kids with mild to moderate peanut allergies. It compares this approach to complete avoidance. The trial also looks at how quality of life is affected and examines immune responses related to different levels of peanut sensitivity.See study design
What are the potential side effects?
Potential side effects may include allergic reactions ranging from mild symptoms like itching or hives to more serious ones such as difficulty breathing. The severity will be closely monitored, especially since participants already have some level of tolerance.

CAFETERIA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 96 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 96 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The difference in the percentage of children that tolerate the full challenge
Secondary outcome measures
Immunoglobulin E
Change in Peanut-specific IgG4
Change in SPT wheal size
+3 more

CAFETERIA Trial Design

2Treatment groups
Active Control
Group I: TreatmentActive Control1 Intervention
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.
Group II: AvoidanceActive Control1 Intervention
Avoids peanut, standard care

Find a Location

Who is running the clinical trial?

Scott SichererLead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,261 Previous Clinical Trials
5,482,933 Total Patients Enrolled
11 Trials studying Food Allergy
12,185 Patients Enrolled for Food Allergy
Scott Sicherer, MDPrincipal Investigator - Icahn School of Medicine at Mount Sinai
Medical School - Johns Hopkins University, Doctor of Medicine
The Mount Sinai Hospital, Residency in Pediatrics
7 Previous Clinical Trials
804 Total Patients Enrolled
2 Trials studying Food Allergy
100 Patients Enrolled for Food Allergy

Media Library

Peanut Protein (Allergen-Specific Immunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03907397 — Phase 2
Food Allergy Research Study Groups: Treatment, Avoidance
Food Allergy Clinical Trial 2023: Peanut Protein Highlights & Side Effects. Trial Name: NCT03907397 — Phase 2
Peanut Protein (Allergen-Specific Immunotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03907397 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Will geriatric participants be included in this investigation?

"As indicated by the inclusionary criteria, this trial is open to those between 4 and 14 years old. Additionally, there are 88 studies for minors under 18 and 158 study opportunities available for people above 65."

Answered by AI

Has the recruitment phase for this trial commenced?

"Affirmative. Clinicaltrials.gov's records demonstrate that this medical experiment, initially posted on August 5th 2019, is enrolling patients. 74 participants must be recruited from 1 of the available sites."

Answered by AI

To whom is participation in this clinical trial being offered?

"This study is seeking 74 children aged 4 to 14 with a confirmed peanut allergy. To be eligible, the patient (or their guardian) must provide informed consent and have IgE levels of 0.35 kUA/L or higher after avoiding peanuts for at least three days before screening. Furthermore, patients should be able to consume between 143 mg and 5043 mg of peanut protein during oral food challenge testing on the day of screening. Informed consent from both parent(s)/guardian(s) and child are necessary in order to participate in this trial."

Answered by AI

Does this medication have governmental sanctioning?

"Adequate prior evidence confirms that this therapeutic intervention is safe, and thus it has been awarded a score of 2 on the Power scale. However, since this is still a Phase 2 trial, data supporting efficacy remains absent."

Answered by AI

What is the upper limit of participants in this experiment?

"That is correct. Clinicaltrials.gov shows that the trial, initially posted on August 5th 2019, is still seeking participants with 74 patients to be recruited from 1 location."

Answered by AI
~13 spots leftby Mar 2025