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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Probiotics are dietary supplements composed of live microorganisms that are normally found within the human microbiome. Probiotics, specifically Lactobacilli and Streptococcus salivarius, have been shown to alter oral microbial composition and to inhibit oral pathogens that contribute to dental caries and periodontal disease. The probiotic chosen for this study is VSL#3, a blend of 8 strains of bacteria, including Lactobacillus and Streptococcus salivarius. VSL#3 has been well tolerated, with minimal adverse effects. VLS#3 was chosen as the treatment substance for this project due to its successful use in trials examining an array of outcomes and its combination of several strains of bacteria.
University of Wisconsin-Madison
Madison, Wisconsin, United States
Change in Oral microbiota profiles- bacterial diversity
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).
Time frame: Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment
Eating Assessment Test (EAT-10)
Patient reported outcome measure for swallowing
Time frame: Baseline visit
Functional Oral Intake Scale (FOIS) Score
Scale used to quantify the amount of oral versus non-oral intake
Time frame: Baseline visit
Kayser-Jones Brief Oral Health Status Examination (BOHSE)
A valid and reliable scoring instrument developed for use with older adults by non-dental health care providers.
Time frame: Baseline visit
Change in Resting Swallow Frequency Rate
We will measure resting swallow frequency using surface electromyography (sEMG).
Time frame: Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment
Change in Residual Mucosal Saliva (RMS)
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
Time frame: Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment
Change in Amount of Saliva Produced
Salivary flow rate (ml/minute) will be calculated under unstimulated and stimulated saliva collection conditions.
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Time frame: Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment