Triclosan, Triclocarban, and the Microbiota
Ключови думи
Резюме
Описание
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.
Дати
| Последна проверка: | 12/31/2011 |
| Първо изпратено: | 01/05/2012 |
| Очаквано записване подадено: | 01/11/2012 |
| Първо публикувано: | 01/12/2012 |
| Изпратена последна актуализация: | 01/11/2012 |
| Последна актуализация публикувана: | 01/12/2012 |
| Действителна начална дата на проучването: | 06/30/2011 |
| Приблизителна дата на първично завършване: | 09/30/2012 |
| Очаквана дата на завършване на проучването: | 11/30/2012 |
Състояние или заболяване
Интервенция / лечение
Other: triclosan/triclocarban-containing personal care products
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Other: 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: 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. |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
| Полове, допустими за проучване | All |
| Приема здрави доброволци | Да |
| Критерии | 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. |
Резултат
Първични изходни мерки
1. Changes in microbial flora [5 months in each phase for a total of 10 month study period]
2. Microbial resistance [5 months in each phase for a total of 10 month study period]
3. Time to alteration in flora. [5 months in each phase for a total of 10 month study period]
