Clinical trial NCT01442701: Stanford's Outcomes Research in Kids
Official title: Stanford's Outcomes Research in Kids (STORK)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacterial, Viral and Other Infectious Agents
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2011-09-28
Enrollment: 361
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


Eligibility 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.

Primary outcomes:
measure: Height-for-weight Z scores
timeFrame: Age 3 years
Secondary outcomes:
measure: Cumulative sick-days
timeFrame: In utero to 3 years of age
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Senior Research Scientist
name: Catherine Ley, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.