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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03539692
Recruitment Status : Recruiting
First Posted : May 29, 2018
Last Update Posted : February 3, 2022
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Sayantani B. Sindher, Stanford University

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

Condition or disease
Food Allergy

Study Design
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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Other
Time Perspective: Other
Official Title: Prescreening Protocol to Enroll in Food Allergy Clinical Studies at a Single Site
Actual Study Start Date : June 10, 2018
Estimated Primary Completion Date : December 10, 2024
Estimated Study Completion Date : December 10, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Outcome of standardized food challenges [ Time Frame: 1 year ]
    Standardized Oral food challenges will occur in a staged manner to diagnose food allergies


Secondary Outcome Measures :
  1. skin testing will occur to evaluate food allergen responses [ Time Frame: 1 year ]
    Standardized skin testing will be performed to detect sensitivity to food allergens


Biospecimen Retention:   Samples With DNA
Blood will be collected, additional samples could include sputum, urine sample, stool sample, oral and nasal samples, skin samples

Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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%)
Contacts and Locations
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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): NCT03539692


Locations
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United States, California
The Sean N. Parker Center for Allergy and Asthma Research, Stanford University Recruiting
Mountain View, California, United States, 94040
Contact: SNP Center Inquiry    650-521-7237    snpcenterallergy_inquiry@stanford.edu   
Sponsors and Collaborators
Stanford University
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Sayantani Sindher, MD Stanford University, SNP Center for Food Allergy and Asthma Research
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sayantani B. Sindher, Clinical Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03539692    
Other Study ID Numbers: 34738
1UM1AI130839-01 ( U.S. NIH Grant/Contract )
FY20ITN384 ( Other Grant/Funding Number: NIH Prime Immune Tolerance Network )
5U19AI104209-07 ( U.S. NIH Grant/Contract )
First Posted: May 29, 2018    Key Record Dates
Last Update Posted: February 3, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate