Trial Information

Triclosan, Triclocarban, and the Microbiota

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

Objectives:

1. Assess diversity and quantities of microbial flora in gut, skin, mouth before, during,
and after TC use

2. Assess whether TC use correlates with microbial resistance

3. 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.