Stanford's Outcomes Research in Kids (STORK)

Stanford University

Status: Completed

Conditions: Bacterial, Viral and Other Infectious Agents

Treatments: Other: Removal of triclosan-containing cleaning products from household.

Study type: Observational

Funder types: Other

Identifiers

NCT01442701

17756 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 361 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

361 participants in 1 patient group

No triclosan / Triclosan

Description:

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.

Treatment:

Other: Removal of triclosan-containing cleaning products from household.