AllergiesNCT01613885
Understanding and Diagnosing Allergic Disease in Twins
An observational study of Allergies, run by Stanford University at 2 sites in United States.
Trial summary
The purpose of this study is to gain better understanding of how the immune system works in twins with and without allergic disease. Healthy volunteers are not specifically targeted. Healthy non-allergic study participants may be found through the course of evaluation for the presence of allergies. Read more about this study
- Who is it for?
- Ages 0 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergies
- How many people
- 340 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2010to Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 0 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Healthy volunteers are not specifically targeted. Healthy non-allergic study participants may be found through the course of evaluation for the presence of allergies. Women, minorities or children will not be excluded from this study.
Who may be able to join
- Twin participants ages 0 to 80 years who are with or without allergy disease.
Who cannot join
- Patients with special risks attendant to venipuncture will be excluded.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sean N Parker Center for Allergy and Asthma Research at Stanford
Stanford, California, 94305
Stanford University School of Medicine
Stanford, California, 94305
About this study
The purpose of this study is to gain better understanding of how the immune system works in twins with and without allergic disease. Healthy volunteers are not specifically targeted. Healthy non-allergic study participants may be found through the course of evaluation for the presence of allergies.
Read the detailed description
The purpose of this study is to study the genetic control and gain better understanding of how the immune system works in twins with and without allergic disease. Although healthy volunteers are not specifically targeted, they might be identified when non-allergic study participants are found through the course of evaluation for the presence of allergies.
- Conditions
- Allergies
- Being tested
- No Intervention
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
This study does not involve any intervention other than obtaining blood, nasal/cheek/throat/skin swabs, saliva, sputum, urine, and stool samples, breathing and skin tests.
| Study group | Role | What they receive |
|---|---|---|
| Twins | Twins that are ages 0 to 80 years, with or without allergy disease. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing immune systems of food allergic twins
Differences in genetic and phenotypic characteristics between twin siblings
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startAug 2010
- Primary completionOct 2019
- Study completionOct 2019
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 AllergiesStudies 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
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kari Christine Nadeau, MD, PhD, Stanford University
- Investigators
- Kari Nadeau, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01613885
- Sponsor's protocol ID
- SU-10042011-8546
- Status last verified
- Mar 2021
- First submitted
- 5 Jun 2012
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Bao R, Hesser LA, He Z, Zhou X, Nadeau KC, Nagler CR. Fecal microbiome and metabolome differ in healthy and food-allergic twins. J Clin Invest. 2021 Jan 19;131(2):e141935. doi: 10.1172/JCI141935.
PubMed 33463536
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding and Diagnosing Allergic Disease in Twins
- ClinicalTrials.gov ID
- NCT01613885
- Acronym / sponsor ID
- SU-10042011-8546
- Conditions
- Allergies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Aug 2010 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 7 Jun 2012 (estimated)
- 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.
The purpose of this study is to gain better understanding of how the immune system works in twins with and without allergic disease. Healthy volunteers are not specifically targeted. Healthy non-allergic study participants may be found through the course of evaluation for the presence of allergies.
Detailed description
The purpose of this study is to study the genetic control and gain better understanding of how the immune system works in twins with and without allergic disease. Although healthy volunteers are not specifically targeted, they might be identified when non-allergic study participants are found through the course of evaluation for the presence of allergies.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Twins | – | Other: No InterventionTwins that are ages 0 to 80 years, with or without allergy disease. |
Who may qualify
- Ages
- 0 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy volunteers are not specifically targeted. Healthy non-allergic study participants may be found through the course of evaluation for the presence of allergies. Women, minorities or children will not be excluded from this study.
Key inclusion criteria (1 listed)
- Twin participants ages 0 to 80 years who are with or without allergy disease.
Key exclusion criteria (1 listed)
- Patients with special risks attendant to venipuncture will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionThis study does not involve any intervention other than obtaining blood, nasal/cheek/throat/skin swabs, saliva, sputum, urine, and stool samples, breathing and skin tests. | Other | Twins |
Primary outcome
Comparing immune systems of food allergic twins
Time frame: 2 years
Differences in genetic and phenotypic characteristics between twin siblings
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Derived from this study: PubMed 33463536Bao R, Hesser LA, He Z, Zhou X, Nadeau KC, Nagler CR. Fecal microbiome and metabolome differ in healthy and food-allergic twins. J Clin Invest. 2021 Jan 19;131(2):e141935. doi: 10.1172/JCI141935.
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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. This study is not recruiting at the moment.
Kari Nadeau, MD, PhD principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergies, run by Stanford University at 2 sites 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 1 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: finished, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing immune systems of food allergic twins (time frame: 2 years). 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 NCT01613885, 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 17 Mar 2021.