NCT01613885

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
340

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2010

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 7, 2012

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

9.2 years

First QC Date

June 5, 2012

Last Update Submit

March 15, 2021

Conditions

Allergies

Outcome Measures

Primary Outcomes (1)

  • Comparing immune systems of food allergic twins

    Differences in genetic and phenotypic characteristics between twin siblings

    2 years

Study Arms (1)

Twins

Twins that are ages 0 to 80 years, with or without allergy disease.

Other: No Intervention

Interventions

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.

Twins

Eligibility Criteria

Age0 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Twin participants ages 0 to 80 years who are with or without allergy disease.

You may not qualify if:

  • Patients with special risks attendant to venipuncture will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sean N Parker Center for Allergy and Asthma Research at Stanford

Stanford, California, 94305, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

  • 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.

    PMID: 33463536DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood, nasal /cheek/throat/skin swab, saliva, urine, stool, sputum

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Kari Nadeau, MD, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 5, 2012

First Posted

June 7, 2012

Study Start

August 1, 2010

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

March 17, 2021

Record last verified: 2021-03

Locations

US(2)