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Stanford's Outcomes Research in Kids (STORK)

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ClinicalTrials.gov Identifier: NCT01442701
Recruitment Status : Unknown
Verified May 2018 by Julie Parsonnet, Stanford University.
Recruitment status was:  Active, not recruiting
First Posted : September 28, 2011
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Julie Parsonnet, Stanford University

Brief 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.

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

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Stanford's Outcomes Research in Kids (STORK)
Actual Study Start Date : November 17, 2011
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Triclosan

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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Cumulative sick-days [ Time Frame: In utero to 3 years of age ]

Biospecimen Retention:   Samples With DNA
Blood, saliva, skin swabs, stool, urine.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01442701


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Study Director: Catherine Ley, PhD Senior Research Scientist
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Julie Parsonnet, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01442701    
Other Study ID Numbers: 17756
First Posted: September 28, 2011    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Communicable Diseases
Infection
Triclosan
Anti-Infective Agents, Local
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents