Food AllergyPrescreenNCT03539692
Prescreening Protocol to Enroll in Food Allergy Clinical Studies at a Single Site
An observational study of Food Allergy, run by Stanford University at 1 site in United States.
Trial summary
This is a protocol for prescreening of participants who would like to be in clinical studies in our Center at Stanford. Read more about this study
- Who is it for?
- Ages 1 week to 90 years
- Conditions the study is for
- Food Allergy
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2018to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 week to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Any individual with possible food allergy (as per their clinical history) who is interested in performing the gold standard food challenge for diagnosis.
Who cannot join
- Any individual who does not consent
- Any individual who is currently taking oral steroids
- Any individual with moderate to severe asthma (FEV1<80%)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Sean N. Parker Center for Allergy and Asthma Research, Stanford University
Palo Alto, California, 94304
SNP Center Inquiry, 650-521-7237, snpcenterallergy_inquiry@stanford.edu
About this study
This is a protocol for prescreening of participants who would like to be in clinical studies in our Center at Stanford.
- Conditions
- Food Allergy
- Medical subject headings
- Food Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome of standardized food challenges
Standardized Oral food challenges will occur in a staged manner to diagnose food allergies
Measured: 1 year
Secondary outcomes (1)
skin testing will occur to evaluate food allergen responses
Standardized skin testing will be performed to detect sensitivity to food allergens
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start10 Jun 2018
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Sayantani B. Sindher, Stanford University
- Investigators
- Sayantani Sindher, MD, Principal investigator, Stanford University, SNP Center for Food Allergy and Asthma Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539692
- Sponsor's protocol ID
- 34738
- Other IDs
- 1UM1AI130839-01, FY20ITN384, 5U19AI104209-07, 5UM1AI82034-02
- Acronym
- Prescreen
- Status last verified
- Jul 2026
- First submitted
- 16 May 2018
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30298065
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prescreening Protocol to Enroll in Food Allergy Clinical Studies at a Single Site
- ClinicalTrials.gov ID
- NCT03539692
- Acronym / sponsor ID
- Prescreen / 34738
- Conditions
- Food Allergy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)
- Study start
- 10 Jun 2018 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 29 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a protocol for prescreening of participants who would like to be in clinical studies in our Center at Stanford.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 1 week to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Any individual with possible food allergy (as per their clinical history) who is interested in performing the gold standard food challenge for diagnosis.
Key exclusion criteria (3 listed)
- Any individual who does not consent
- Any individual who is currently taking oral steroids
- Any individual with moderate to severe asthma (FEV1<80%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Outcome of standardized food challenges
Time frame: 1 year
Standardized Oral food challenges will occur in a staged manner to diagnose food allergies
1 secondary outcome
skin testing will occur to evaluate food allergen responses
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Derived from this study: PubMed 30298065Purington 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sayantani Sindher, MD principal investigator
Stanford University, SNP Center for Food Allergy and Asthma Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Allergy, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SNP Center Inquiry (650-521-7237, snpcenterallergy_inquiry@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome of standardized food challenges (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03539692, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.