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Completed

NCT Number: NCT01509976

Triclosan, Triclocarban, and the Microbiota

Triclosan (5-chloro-2 (22,4-dichlorophenoxy)phenol) is a broad-spectrum antibacterial and antifungal agent that is found in thousands of common household products, including deodorants, toothpaste, "antibacterial" soaps, cleaning products, kitchen utensils, bedding, socks, trash bags. The benefits of triclosan have not been proven except in reducing plaque and gingivitis when used in toothpaste. In this study, the investigators intend to look at whether exposure to triclosan changes the colonizing flora of the skin, gut and mouth as well as changes in certain blood hormone levels, including adipocytokines, androgens, and inflammatory markers. Changes in the gut microbiota have been associated with a variety of disease states such as inflammatory bowel disease, colorectal cancer. Additionally, reductions in the microbiome diversity have been associated with obesity.

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Key information

Conditions

Triclosan Effects on Microbial Flora Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

About this study

Hypothesis: Exposure to triclosan changes microbial flora and leads to changes in

Objectives:

  • Assess diversity and quantities of microbial flora in gut, skin, mouth before, during, and after TC use
  • Assess whether TC use correlates with microbial resistance
  • If any, assess time to change in alterations in microbial flora

Study design:

Prospective, randomized, double-blinded, cross-over study of 20 subjects

Here, we propose a pilot study in which we will compare the microbial flora of subjects who use triclosan-containing personal hygiene products and those who use triclosan-free products. We will randomize half the cohort to triclosan-containing personal hygiene products including toothpaste, liquid hand soap, bar soap, and dish soap for half of the cohort for a 5-month period of time. The participants and investigators will be blinded as to whether they are using triclosan-containing products or triclosan-free products by blinding the packaging. After about 5 months, the participants will cross-over to the other arm.

During a lead-in period of about 2 weeks, we will collect urine samples for a baseline triclosan level and body weight. We will also collect Leptin, Resistin, Grehlin, IL 10, IL17, PAI-1 Plasminogen activator inhibitor -1, TNFa, IFN-g, Insulin, IGF, Glucagon, CRP, TSH, Free T4T3, Estradiol, Testosterone free, Testosterone total, Adiponectin, IL6, Visfatin, H. pylori, ESR. Blood, urine, and body weight will be collected at three points in the study: prior to first phase, in between phases, and after completion of second phase.

We will collect stool, skin, tooth, and saliva samples multiple times throughout the study and submit for pyrosequencing.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Health subjects
  • Age >18 years

Exclusion criteria

  • Pregnancy
  • Recent travel to the developing world (within 3 months)
  • Recent use of antibiotics (within 3 months)
  • Unwillingness to change personal care/hygiene products
  • Recent gastrointestinal illness (within 3 months)
  • Individuals who are unlikely to be available for the 10 months of the study period.

Treatment and study plan

triclosan/triclocarban-containing personal care products

Other

Subjects will be randomly assigned to one of two arms with either triclosan/triclocarban-containing personal care products or products without triclosan/triclocarban. After 5 months, each subject will cross over to the other arm.

Primary outcomes

  1. Changes in microbial flora

    Time frame: 5 months in each phase for a total of 10 month study period

    We will assess diversity and quantities of microbial flora in gut, skin, mouth before, during, and after triclosan use.

  2. Microbial resistance

    Time frame: 5 months in each phase for a total of 10 month study period

    We will assess whether triclosan use correlates with microbial resistance

  3. Time to alteration in flora.

    Time frame: 5 months in each phase for a total of 10 month study period

    We will assess time to change in alterations in microbial flora, if any.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2017
First posted
Jan 13, 2012
Registry last updated
Mar 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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