Triclosan, Triclocarban, and the Microbiota

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Triclosan, Triclocarban, and the Microbiota

Conditions
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Triclosan Effects on Microbial Flora

Intervention / Treatment
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* Other: triclosan/triclocarban-containing personal care products


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Red<br>This arm will either start with personal care products that contain triclosan and then and cross over to personal care products that do not contain triclosan or vice-versa. Since the investigators are blinded, it is not clear which arm is which. | Other: triclosan/triclocarban-containing personal care products<br>* 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.<br>|
| Other: Blue<br>This arm will either start with personal care products that contain triclosan and then and cross over to personal care products that do not contain triclosan or vice-versa. Since the investigators are blinded, it is not clear which arm is which. | Other: triclosan/triclocarban-containing personal care products<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in microbial flora | We will assess diversity and quantities of microbial flora in gut, skin, mouth before, during, and after triclosan use. | 5 months in each phase for a total of 10 month study period | 
| Microbial resistance | We will assess whether triclosan use correlates with microbial resistance | 5 months in each phase for a total of 10 month study period | 
| Time to alteration in flora. | We will assess time to change in alterations in microbial flora, if any. | 5 months in each phase for a total of 10 month study period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Triclosan, Triclocarban, Microbial flora