Impact of Probiotics on Oral Microbiota in Older Adults With Dysphagia
- Conditions
- Dysphagia
- Interventions
- Drug: VSL#3
- Registration Number
- NCT03682094
- Lead Sponsor
- University of Wisconsin, Madison
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Probiotic VSL#3 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.
- Primary Outcome Measures
Name Time Method Change in Oral microbiota profiles- bacterial diversity 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).
- Secondary Outcome Measures
Name Time Method Functional Oral Intake Scale (FOIS) Score Baseline visit Scale used to quantify the amount of oral versus non-oral intake
Eating Assessment Test (EAT-10) Baseline visit Patient reported outcome measure for swallowing
Change in Resting Swallow Frequency Rate Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment We will measure resting swallow frequency using surface electromyography (sEMG).
Kayser-Jones Brief Oral Health Status Examination (BOHSE) Baseline visit A valid and reliable scoring instrument developed for use with older adults by non-dental health care providers.
Change in Residual Mucosal Saliva (RMS) Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment Residual Mucosal Saliva will be collected from the anterior hard palate (AHP), buccal (BUC), anterior tongue (AT), and lower labial (LL) surfaces using SialoPaper strips
Change in Amount of Saliva Produced Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment Salivary flow rate (ml/minute) will be calculated under unstimulated and stimulated saliva collection conditions.
Trial Locations
- Locations (1)
University of Wisconsin-Madison
🇺🇸Madison, Wisconsin, United States