Impact of Probiotics on Oral Microbiota in Older Adults With Dysphagia

Dysphagia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03682094
• Other study ID #: 2018-0428
• Secondary ID: A534255SMPH/MEDI
• Status: Suspended
• Phase: Early Phase 1
• Start date: August 13, 2018
• Est. completion date: March 2024

Study information

• Verified date: July 2023
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Suspended
• Enrollment: 20
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia

Intervention

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.

Locations

Country	Name	City	State
United States	University of Wisconsin-Madison	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment
Secondary	Eating Assessment Test (EAT-10)	Patient reported outcome measure for swallowing	Baseline visit
Secondary	Functional Oral Intake Scale (FOIS) Score	Scale used to quantify the amount of oral versus non-oral intake	Baseline visit
Secondary	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.	Baseline visit
Secondary	Change in Resting Swallow Frequency Rate	We will measure resting swallow frequency using surface electromyography (sEMG).	Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment
Secondary	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	Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment
Secondary	Change in Amount of Saliva Produced	Salivary flow rate (ml/minute) will be calculated under unstimulated and stimulated saliva collection conditions.	Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment