Overview

This trial is active, not recruiting.

Condition bacterial, viral and other infectious agents
Treatment removal of triclosan-containing cleaning products from household.
Sponsor Stanford University
Start date March 2010
End date June 2017
Trial size 200 participants
Trial identifier NCT01442701, 17756

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.
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.

Primary Outcomes

Measure
Height-for-weight Z scores
time frame: Age 3 years

Secondary Outcomes

Measure
Cumulative sick-days
time frame: In utero to 3 years of age

Eligibility Criteria

Female participants at least 18 years old.

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.

Additional Information

Official title Stanford's Outcomes Research in Kids (STORK)
Principal investigator Catherine Ley, PhD
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Stanford University.