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Triclosan, Triclocarban, and the Microbiota

This study is currently recruiting participants.
Verified January 2012 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01509976
First received: January 6, 2012
Last updated: January 12, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention
Triclosan Effects on Microbial Flora.
 Other: triclosan/triclocarban-containing personal care products

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Triclosan, Triclocarban, and the Microbiota

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Changes in microbial flora [ Time Frame: 5 months in each phase for a total of 10 month study period ] [ Designated as safety issue: No ]
    We will assess diversity and quantities of microbial flora in gut, skin, mouth before, during, and after triclosan use.

  • Microbial resistance [ Time Frame: 5 months in each phase for a total of 10 month study period ] [ Designated as safety issue: No ]
    We will assess whether triclosan use correlates with microbial resistance

  • Time to alteration in flora. [ Time Frame: 5 months in each phase for a total of 10 month study period ] [ Designated as safety issue: No ]
    We will assess time to change in alterations in microbial flora, if any.


Estimated Enrollment: 20
Study Start Date: July 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Red
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
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.
Blue
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
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509976

Contacts
Contact: Gina A Suh, MD 650-724-8434 gsuh@stanford.edu
Contact: Jade Riotto 650-725-4561 jriotto@stanford.edu

Locations
United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Gina A Suh, MD     650-724-8434     gsuh@stanford.edu    
Contact: Jade Riotto     650-724-8434     jriotto@stanford.edu    
Principal Investigator: Julie Parsonnet, MD            
Sub-Investigator: Gina A Suh, MD            
Sponsors and Collaborators
Stanford University
  More Information

Publications:

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01509976     History of Changes
Other Study ID Numbers: AVOCET
Study First Received: January 6, 2012
Last Updated: January 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Triclosan
Triclocarban
Microbial flora
Obesity

Additional relevant MeSH terms:
Triclosan
Hexachlorophene
Triclocarban
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Lipid Regulating Agents

ClinicalTrials.gov processed this record on May 19, 2013