Stanford's Outcomes Research in Kids (STORK)

Stanford's Outcomes Research in Kids (STORK)

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.

Study Overview

• Status: Completed
• Conditions: Bacterial, Viral and Other Infectious Agents
• Intervention / Treatment: Other: Removal of triclosan-containing cleaning products from household.

• Study Type: Observational
• Enrollment (Actual): 361

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The study population will be enrolled from the population of pregnant women attending obstetric clinics for the first antenatal visit. Each woman will be followed throughout her pregnancy and then she and her baby will be followed over the first three years of the baby's life (and more if possible).

Description

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to participate in the study:

1. Able to provide written informed consent.
2. Able to communicate effectively in verbal English or Spanish.
3. Willing to provide blood, saliva, urine and stool specimens from herself, and willing to provide blood, saliva, urine and stool specimens from her infant.
4. 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:

1. More than one fetus.
2. High risk pregnancy.
3. Intent to move from the Bay Area within three years after enrollment.
4. History of diagnosis and/or treatment, and any current diagnosis or treatment, of type 1 diabetes or of major mental illness.
5. History of diagnosis and/or treatment, and any current diagnosis or treatment, of a thyroid disorder or other endocrine condition.
6. History of diagnosis and/or treatment, and any current diagnosis or treatment that has resulted in severe immunosuppression.
7. A household member who has a compromised immune system
8. Other conditions that in the opinion of the PI would make the subject an unacceptable candidate for this study.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

No triclosan / Triclosan; 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.; 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.

What is the study measuring?

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	Time Frame
Cumulative sick-days	In utero to 3 years of age

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Study Director: Catherine Ley, PhD, Senior Research Scientist

Publications and helpful links

General Publications

• Ribado JV, Ley C, Haggerty TD, Tkachenko E, Bhatt AS, Parsonnet J. Household triclosan and triclocarban effects on the infant and maternal microbiome. EMBO Mol Med. 2017 Dec;9(12):1732-1741. doi: 10.15252/emmm.201707882.
• Ley C, Pischel L, Parsonnet J. Triclosan and triclocarban exposure and thyroid function during pregnancy-A randomized intervention. Reprod Toxicol. 2017 Dec;74:143-149. doi: 10.1016/j.reprotox.2017.09.005. Epub 2017 Sep 20.
• Ley C, Sanchez Mde L, Mathur A, Yang S, Sundaram V, Parsonnet J. Stanford's Outcomes Research in Kids (STORK): a prospective study of healthy pregnant women and their babies in Northern California. BMJ Open. 2016 Apr 13;6(4):e010810. doi: 10.1136/bmjopen-2015-010810.

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2011
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: September 1, 2011
• First Submitted That Met QC Criteria: September 26, 2011
• First Posted (Estimate): September 28, 2011

Study Record Updates

• Last Update Posted (Actual): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 16, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Antimetabolites; Hypolipidemic Agents; Lipid Regulating Agents; Fatty Acid Synthesis Inhibitors; Triclosan
• Other Study ID Numbers: 17756 (REB)