Bacterial, Viral and Other Infectious Agents Clinical Trial
— STORKOfficial title:
Stanford's Outcomes Research in Kids (STORK)
| NCT number | NCT01442701 |
| Other study ID # | 17756 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 17, 2011 |
| Est. completion date | December 1, 2019 |
| Verified date | March 2021 |
| Source | Stanford University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 361 |
| Est. completion date | December 1, 2019 |
| Est. primary completion date | December 1, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Stanford University | Stanford | California |
| Lead Sponsor | Collaborator |
|---|---|
| Stanford University |
United States,
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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Height-for-weight Z scores | We will determine whether an association exists between height-for-weight Z-score (with adjustment for age and sex) and infectious disease load. | Age 3 years | |
| Secondary | Cumulative sick-days | In utero to 3 years of age |