Stanford University
Stanford, California, 94305, United States
Completed
NCT Number: NCT01442701
Stanford's Outcomes Research in Kids
The investigators intend to investigate whether the rise in childhood obesity is caused by the loss of recurrent and chronic infections in modern, industrialized society, beginning in utero and extending through early childhood. The investigators will also examine whether the antimicrobial triclosan, present in numerous cleaning and hygiene products, decreases the incidence of infection within a household.
Completed
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Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Subjects must meet all of the following inclusion criteria to participate in the study:
- Able to provide written informed consent.
- Able to communicate effectively in verbal English or Spanish.
- Willing to provide blood, saliva, urine and stool specimens from herself, and willing to provide blood, saliva, urine and stool specimens from her infant.
- Willing to provide consent for review of Primary Provider Medical Records regarding, for the mother, medical history and infectious and other conditions during pregnancy, and for the infant, Apgar scores, height and weight measurements at birth and over time, infectious and other disease diagnoses and treatment, and vaccination records.
Exclusion criteria
- More than one fetus.
- High risk pregnancy.
- Intent to move from the Bay Area within three years after enrollment.
- History of diagnosis and/or treatment, and any current diagnosis or treatment, of type 1 diabetes or of major mental illness.
- History of diagnosis and/or treatment, and any current diagnosis or treatment, of a thyroid disorder or other endocrine condition.
- History of diagnosis and/or treatment, and any current diagnosis or treatment that has resulted in severe immunosuppression.
- A household member who has a compromised immune system
- Other conditions that in the opinion of the PI would make the subject an unacceptable candidate for this study.
Treatment and study plan
Removal of triclosan-containing cleaning products from household.
OtherAn intervention is nested within the observational cohort study as a secondary outcome. Commercially available household and personal cleaning products that either do not contain triclosan or that may contain triclosan will be delivered to the household every 4 months for the duration of the study. All cleaning products will be formulated, packaged and labeled by the original manufacturer with no modification for this study. Use of these products will be as per each individual product's label and at the discretion of the participant.
Primary outcomes
-
Height-for-weight Z scores
Time frame: Age 3 years
We will determine whether an association exists between height-for-weight Z-score (with adjustment for age and sex) and infectious disease load.
Secondary outcomes
-
Cumulative sick-days
Time frame: In utero to 3 years of age
Sponsors and collaborators
Lead sponsor
Stanford University
Other
Registry information
Official study title
Stanford's Outcomes Research in Kids (STORK)
Acronym: STORK
Important dates
- Study start
- 2011
- Primary completion
- 2019
- Study completion
- 2019
- First posted
- Sep 28, 2011
- Registry last updated
- Mar 17, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.