Clinical trial NCT03682094: Impact of Probiotics on Oral Microbiota in Older Adults With Dysphagia
Official title: Impact of Probiotics on Oral Microbiota in Older Adults With Dysphagia at Risk for Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Dysphagia
Keywords: probiotics
oral microbiome
dysphagia
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2018-09-24
Enrollment: 9
Sex: ALL
Minimum age (years): 65
Maximum age (years): 99
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria

1. 65 years of age or older
2. Dysphagia diagnosis based on videofluoroscopic swallow study with observed airway invasion (Penetration-Aspiration Scale score of 3 or higher)
3. Ability to provide consent
4. Ability to submit oral samples
5. Ability to swallow sachet of probiotic (dissolved in thickened liquid, as needed)
6. Ability to return to UWHC for week 2 and week 4 visits.

Exclusion Criteria

1. Currently taking antibiotics or probiotics
2. Actively receiving immunosuppressive therapy
3. Non-oral feeding with inability to swallow probiotic
4. diagnosis of head and neck cancer or upper airway disease
5. prior surgery to the head and neck region that would have affected the muscles of swallowing or the salivary glands
6. history of chemotherapy or radiation to the head and neck region
7. severe periodontal disease.
8. currently pregnant or planning to become pregnant

Primary outcomes:
measure: Change in Oral microbiota profiles- bacterial diversity
timeFrame: Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment
Secondary outcomes:
measure: Eating Assessment Test (EAT-10)
timeFrame: Baseline visit
measure: Functional Oral Intake Scale (FOIS) Score
timeFrame: Baseline visit
measure: Kayser-Jones Brief Oral Health Status Examination (BOHSE)
timeFrame: Baseline visit
measure: Change in Resting Swallow Frequency Rate
timeFrame: Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment
measure: Change in Residual Mucosal Saliva (RMS)
timeFrame: Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment
measure: Change in Amount of Saliva Produced
timeFrame: Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
References: