Triclosan, Triclocarban, and the Microbiota
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
20 participants in 2 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal