Impact of Probiotics on Oral Microbiota in Older Adults With Dysphagia

NCT ID: NCT03682094

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-27
• Study Completion Date: 2020-01-21

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.

Conditions

Dysphagia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Probiotic

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.

Group Type: EXPERIMENTAL

VSL#3

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

probiotic

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Wisconsin-Madison

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

A534255

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/MEDICINE/GER-AD DEV

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 3/11/2019

Identifier Type: OTHER

Identifier Source: secondary_id

2018-0428

Identifier Type: -

Identifier Source: org_study_id