Effects of Mouthrinses on the Microbiome of the Oral Cavity and GI Tract
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- viral load and mRNA analysis using RT-PCR
研究概览
简要总结
The purpose of this research study is to identify the effects of 2 over-the-counter mouthwashes on bacteria and 3 viruses in the participant's mouth and gut. The participant will be randomly allocated to rinse their mouth twice daily either with Listerine mouthwash, Lumineux Oral Essentials mouthwash, or water. The overall duration of the study will be approximately 180 days and will include approximately 5 visits and 15-30 minutes for each visit with a total of approximately 2.5 hours of your time. Additionally, fecal matter will also be collected in some subjects using a commercial collection kit.
详细描述
Goal of this pilot study is to identify the effects of 2 over-the-counter mouthrinses on the microbiome of the oral cavity and the GI tract. We will investigate 2 mouthwashes, plus an additional non-treatment group (water rinse only). One mouthwash has antimicrobial activity (ListerineR, Johnson & Johnson Consumer Healthcare Products, Skillman, New Jersey); the other targets microbial products only (Lumineux Oral Essentials Clean and Fresh MouthwashR, Los Angeles, CA). Oral plaque will be collected with a sterile swab using a commercial collection kit on Day 0, Day 30, Day 60, Day 90, and Day 180 of the study. Additionally, fecal matter will also be collected in some subjects using a commercial collection kit. Subjects will rinse 2x daily for approximately 180 days using either mouthwash or water.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
White tape over receptacle
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eligible men and non-pregnant and non-lactating women of all races age 18-
- •Volunteers must consent to participate in all scheduled exam visits and procedures.
- •Volunteers must be available for follow up on the telephone.
- •Healthy gums or gums that bleed when you brush them.
排除标准
- •Volunteers unable or unwilling to sign the informed consent form.
- •Less than 20 teeth (excluding third molars).
- •Individuals who have taken antibiotics in the previous 3 months.
- •Presence of any condition, abnormality, or situation at Baseline that in the opinion of the Principal Investigator may preclude the volunteer's ability to comply with study requirements, including completion of the study or the quality of the data.
研究组 & 干预措施
Water rinse
rinse twice daily for 1 min with water
干预措施: Lumineux Oral Essentials rinse (Other)
Water rinse
rinse twice daily for 1 min with water
干预措施: Listerine rinse (Other)
Lumineux Oral Essentials rinse
rinse twice daily for 1 min with Lumineux Oral Essentials rinse
干预措施: Listerine rinse (Other)
Listerine rinse
rinse twice daily for 1 min with Listerine rinse
干预措施: Lumineux Oral Essentials rinse (Other)
结局指标
主要结局
viral load and mRNA analysis using RT-PCR
时间窗: Day 180
viral load: HSV1, CMV, EBV
total bacterial load and mRNA analysis
时间窗: Day 180
total bacterial load as determined from oral swabs and collected fecal samples, followed by subsequent standard mRNA analysis using RT-PCR
viral load and mRNA analysis using RT-PCR
时间窗: Day 30
viral load: HSV1, CMV, EBV
total bacterial load and mRNA analysis
时间窗: Day 0
total bacterial load as determined from oral swabs and collected fecal samples, followed by subsequent standard mRNA analysis using RT-PCR
total bacterial load and mRNA analysis
时间窗: Day 30
total bacterial load as determined from oral swabs and collected fecal samples, followed by subsequent standard mRNA analysis using RT-PCR
total bacterial load and mRNA analysis
时间窗: Day 60
total bacterial load as determined from oral swabs and collected fecal samples, followed by subsequent standard mRNA analysis using RT-PCR
total bacterial load and mRNA analysis
时间窗: Day 90
total bacterial load as determined from oral swabs and collected fecal samples, followed by subsequent standard mRNA analysis using RT-PCR
viral load and mRNA analysis using RT-PCR
时间窗: Day 0
viral load: HSV1, CMV, EBV
viral load and mRNA analysis using RT-PCR
时间窗: Day 60
viral load: HSV1, CMV, EBV
viral load and mRNA analysis using RT-PCR
时间窗: Day 90
viral load: HSV1, CMV, EBV
次要结局
未报告次要终点
研究者
Petra E. Wilder-Smith
Professor of Surgery and Director of Dentistry
University of California, Irvine