Prescreening Protocol to Enroll in Food Allergy Clinical Studies at a Single Site (Prescreen)

This is a protocol for prescreening of participants who would like to be in clinical studies in our Center at Stanford.

Study Overview

• Status: Recruiting
• Conditions: Food Allergy

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: SNP Center Inquiry; Phone Number: 650-521-7237; Email: snpcenterallergy_inquiry@stanford.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Recruiting
      • The Sean N. Parker Center for Allergy and Asthma Research, Stanford University
      • Contact: SNP Center Inquiry; Phone Number: 650-521-7237; Email: snpcenterallergy_inquiry@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Ages 1 wk-90 yrs will be screened and enrolled in this study to determine if they have a clinically-relevant food allergy. If so, they could be eligible for interventional clinical trials in the future.

Description

Inclusion Criteria:

• Any individual with possible food allergy (as per their clinical history) who is interested in performing the gold standard food challenge for diagnosis.

Exclusion Criteria:

• Any individual who does not consent
• Any individual who is currently taking oral steroids
• Any individual with moderate to severe asthma (FEV1<80%)

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Outcome of standardized food challenges	Standardized Oral food challenges will occur in a staged manner to diagnose food allergies	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
skin testing will occur to evaluate food allergen responses	Standardized skin testing will be performed to detect sensitivity to food allergens	1 year

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Sayantani Sindher, MD, Stanford University, SNP Center for Food Allergy and Asthma Research

Publications and helpful links

General Publications

• Purington N, Chinthrajah RS, Long A, Sindher S, Andorf S, O'Laughlin K, Woch MA, Scheiber A, Assa'ad A, Pongracic J, Spergel JM, Tam J, Tilles S, Wang J, Galli SJ, Desai M, Nadeau KC. Eliciting Dose and Safety Outcomes From a Large Dataset of Standardized Multiple Food Challenges. Front Immunol. 2018 Sep 21;9:2057. doi: 10.3389/fimmu.2018.02057. eCollection 2018.

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2018
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 16, 2018
• First Submitted That Met QC Criteria: May 16, 2018
• First Posted (Actual): May 29, 2018

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: 34738; 1UM1AI130839-01 (U.S. NIH Grant/Contract); 5U19AI104209-07 (U.S. NIH Grant/Contract); FY20ITN384 (Other Grant/Funding Number: NIH Prime Immune Tolerance Network)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No