NCT03682094

Impact of Probiotics on Oral Microbiota in Older Adults With Dysphagia

Impact of Probiotics on Oral Microbiota in Older Adults With Dysphagia at Risk for Pneumonia

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 65 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dysphagia

Interventions

Type	Name	Description
DRUG	VSL#3	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.

Timeline

• Start date: 2018-08-27
• Primary completion: 2020-01-21
• Completion: 2020-01-21
• First posted: 2018-09-24
• Last updated: 2024-05-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study