Impact of Probiotics on Oral Microbiota in Older Adults With Dysphagia at Risk for Pneumonia
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Change in Oral microbiota profiles- bacterial diversity
研究概览
简要总结
The overall purpose of this study is to characterize the effect of probiotics on the oral microbiota in older adults with dysphagia at risk for pneumonia.
详细描述
The goal of this pilot study is to characterize the effects of probiotics on the oral microbiota in older patients with dysphagia at risk for pneumonia. A total of 20 participants will be recruited from the UW Health Inpatient Swallowing Consult Service. Participants will have a dysphagia diagnosis along with documented aspiration on videofluoroscopy. Each participant will receive a once daily VSL#3 probiotic blend (dissolved in thickened liquid as applicable) for 28 days. A baseline assessment will be completed to collect data on demographics, health history and behaviors, usual diet, level of oral intake, and patient-reported swallow function. Oral swab (buccal mucosa and tongue dorsum) as well as saliva sample collections will be completed. Data on adherence and adverse events will be collected weekly. Bacterial DNA will be extracted from oral samples and 16S rRNA sequencing techniques will be used to identify contents of oral microbiota at baseline, week 2, and week 4. Oral microbial composition will be compared between the time points, and treatment feasibility (recruitment and retention rates) in this population will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking.
入排标准
- 年龄范围
- 65 Years 至 99 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Probiotic
The treatment will consist of VSL#3, 3 grams (g), taken orally once a day for 4 weeks. The VSL#3 will be delivered in the form of a sachet of freeze-dried powder. Participants will be instructed to mix the sachets with water to consume. Those participants taking thickened liquids will mix the sachet with liquids thickened to the level (nectar versus honey) prescribed by their clinician. In order to facilitate delivery of the probiotic solution throughout the oral cavity, participants will be instructed to swish the solution in the mouth for up to 10 seconds (as tolerated) prior to each swallow.
干预措施: VSL#3 (Drug)
结局指标
主要结局
Change in Oral microbiota profiles- bacterial diversity
时间窗: Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment
Next generation sequencing will be used to quantify the amount of alpha and beta diversity in samples collected from various locations in the oral cavity (buccal mucosa, dorsum of the tongue, saliva).
次要结局
- Functional Oral Intake Scale (FOIS) Score(Baseline visit)
- Eating Assessment Test (EAT-10)(Baseline visit)
- Change in Resting Swallow Frequency Rate(Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment)
- Kayser-Jones Brief Oral Health Status Examination (BOHSE)(Baseline visit)
- Change in Residual Mucosal Saliva (RMS)(Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment)
- Change in Amount of Saliva Produced(Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment)