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Stanford's Outcomes Research in Kids (STORK)

This study is currently recruiting participants.
Verified September 2011 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Julie Parsonnet, Stanford University
ClinicalTrials.gov Identifier:
NCT01442701
First received: September 1, 2011
Last updated: September 26, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention
Bacterial, Viral and Other Infectious Agents
 Other: Removal of triclosan-containing cleaning products from household.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Stanford's Outcomes Research in Kids (STORK)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Height-for-weight Z scores [ Time Frame: Age 3 years ] [ Designated as safety issue: No ]
    We will determine whether an association exists between height-for-weight Z-score (with adjustment for age and sex) and infectious disease load.


Secondary Outcome Measures:
  • Cumulative sick-days [ Time Frame: In utero to 3 years of age ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood, saliva, skin swabs, stool, urine.


Estimated Enrollment: 200
Study Start Date: March 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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).

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01442701

Contacts
Contact: Luz Sanchez 650-724-4947 mluz@stanford.edu

Locations
United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Luz Sanchez     650-724-4947     mluz@stanford.edu    
Principal Investigator: Julie Parsonnet, MD            
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Catherine Ley, PhD Senior Research Scientist
  More Information

No publications provided

Responsible Party: Julie Parsonnet, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01442701     History of Changes
Other Study ID Numbers: 17756
Study First Received: September 1, 2011
Last Updated: September 26, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Communicable Diseases
Infection
Triclosan
Hexachlorophene
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Lipid Regulating Agents

ClinicalTrials.gov processed this record on May 21, 2013