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Triclosan, Triclocarban, and the Microbiota

Triclosan, Triclocarban, and the Microbiota

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01509976
Enrollment
20
Registered
2012-01-13
Start date
2011-07-01
Completion date
2017-12-31
Last updated
2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Triclosan Effects on Microbial Flora

Keywords

Triclosan, Triclocarban, Microbial flora, Obesity

Brief summary

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

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.

Interventions

OTHERtriclosan/triclocarban-containing personal care products

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.

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Changes in microbial flora5 months in each phase for a total of 10 month study periodWe will assess diversity and quantities of microbial flora in gut, skin, mouth before, during, and after triclosan use.
Microbial resistance5 months in each phase for a total of 10 month study periodWe will assess whether triclosan use correlates with microbial resistance
Time to alteration in flora.5 months in each phase for a total of 10 month study periodWe will assess time to change in alterations in microbial flora, if any.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026