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

NCT03539692 | Recruiting

• 5 other identifiers: 347381UM1AI130839-01FY20ITN3845U19AI104209-075UM1AI82034-02
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Food Allergy

Outcome Measures

Primary Outcomes (1)

• Outcome of standardized food challenges

  Standardized Oral food challenges will occur in a staged manner to diagnose food allergies

  1 year

Secondary Outcomes (1)

• skin testing will occur to evaluate food allergen responses

  1 year

Eligibility Criteria

• Age: 1 Week - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

The Sean N. Parker Center for Allergy and Asthma Research, Stanford University

Palo Alto, California, 94304, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 30298065 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood will be collected, additional samples could include sputum, saliva, urine sample, stool sample, oral and nasal samples, skin samples

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Sayantani Sindher, MD

  Stanford University, SNP Center for Food Allergy and Asthma Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SNP Center Inquiry

CONTACT

650-521-7237; snpcenterallergy_inquiry@stanford.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: May 29, 2018
• Study Start: June 10, 2018
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 2, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)