NCT05972330已完成不适用
Testing the Efficacy of VRx MyBiotics Oral Lozenges to Improve the Oral Microbiome
Viome2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2023年6月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Viome Oral Health Score
研究概览
简要总结
This study will test the efficacy of Viome's VRx MyBiotics Oral Lozenges at improving the oral microbiome.
详细描述
This is a single arm, interventional trial on adults residing in the United States. The study will test the efficacy of personalized oral biotic lozenges (VRx MyBiotics Oral Lozenges) at improving oral microbiome health according to Viome's Oral Health Score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
None, Open Label
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
- •Any person with a US address that is 18 years old or older
- •Able to speak and read English
- •Willing and able to follow the trial instructions, as described in the recruitment letter
- •Signed and dated informed consent prior to any trial-specific procedures.
排除标准
- •Systemic antibiotic treatment 30 days prior to enrollment or during the trial
- •Not willing to stop sporadic use (less frequently than daily) of any mouthwash.
- •Significant diet, supplements, or lifestyle change in the previous 1 month or next 2 months once enrolled
- •Allergy to tapioca, peppermint, or sweet potato
- •Current diagnosis of periodontitis or other advanced oral disease (chronic recurrent caries, oral cancer, etc)
- •No dental procedures 30 days prior to enrollment or during the trial (regular cleanings, bone grafts, dental implants, etc)
- •Pregnancy or planned pregnancy
- •Currently have cancer or undergoing cancer therapy
- •Fewer than 20 teeth
- •Use of at home teeth whitening products 30 days prior to enrollment or during the trial
- •Start new medications or supplements during the trial
结局指标
主要结局
Viome Oral Health Score
时间窗: ~ 4 months
Increase in oral health score as measured by Viome's Oral Health Score.
次要结局
未报告次要终点
研究者
研究点 (2)
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