Stanford's Outcomes Research in Kids

Completed

• Conditions: Bacterial, Viral and Other Infectious Agents
• Interventions: Other: Removal of triclosan-containing cleaning products from household.

• Registration Number: NCT01442701
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-01
• Study First Submitted QC: 2011-09-26
• Study First Posted: 2011-09-28
• Study Start: 2011-11-17
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-16
• Last Update Posted: 2021-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 361

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No triclosan / Triclosan	Removal of triclosan-containing cleaning products from household.	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.

Primary Outcome Measures

Name	Time	Method
Height-for-weight Z scores	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

Name	Time	Method
Cumulative sick-days	In utero to 3 years of age

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States