Stanford's Outcomes Research in Kids

Study Overview
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Brief Summary
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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.

Official Title
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Stanford's Outcomes Research in Kids (STORK)

Conditions
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Bacterial, Viral and Other Infectious Agents

Intervention / Treatment
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* Other: Removal of triclosan-containing cleaning products from household.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No triclosan / Triclosan<br>Participants are randomized to receive household and personal cleaning products from one of 2 arms: products that either do not contain triclosan or that may contain triclosan. Participants select products from an arm-specific list of commercially available items. | Other: Removal of triclosan-containing cleaning products from household.<br>* An 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Height-for-weight Z scores | We will determine whether an association exists between height-for-weight Z-score (with adjustment for age and sex) and infectious disease load. | Age 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative sick-days |  | In utero to 3 years of age |