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Impact of Probiotics on Oral Microbiota in Older Adults With Dysphagia

Primary Purpose

Dysphagia

Status
Suspended
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
VSL#3
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysphagia focused on measuring probiotics, oral microbiome, dysphagia

Eligibility Criteria

65 Years - 99 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Wisconsin-Madison

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Probiotic

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Eating Assessment Test (EAT-10)
Patient reported outcome measure for swallowing
Functional Oral Intake Scale (FOIS) Score
Scale used to quantify the amount of oral versus non-oral intake
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.
Change in Resting Swallow Frequency Rate
We will measure resting swallow frequency using surface electromyography (sEMG).
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
Change in Amount of Saliva Produced
Salivary flow rate (ml/minute) will be calculated under unstimulated and stimulated saliva collection conditions.

Full Information

First Posted
August 21, 2018
Last Updated
July 28, 2023
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT03682094
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Suspended
Why Stopped
Interim Analysis / Resource Availability
Study Start Date
August 13, 2018 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia
Keywords
probiotics, oral microbiome, dysphagia

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
No masking.
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotic
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
VSL#3
Other Intervention Name(s)
probiotic
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Oral microbiota profiles- bacterial diversity
Description
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
Secondary Outcome Measure Information:
Title
Eating Assessment Test (EAT-10)
Description
Patient reported outcome measure for swallowing
Time Frame
Baseline visit
Title
Functional Oral Intake Scale (FOIS) Score
Description
Scale used to quantify the amount of oral versus non-oral intake
Time Frame
Baseline visit
Title
Kayser-Jones Brief Oral Health Status Examination (BOHSE)
Description
A valid and reliable scoring instrument developed for use with older adults by non-dental health care providers.
Time Frame
Baseline visit
Title
Change in Resting Swallow Frequency Rate
Description
We will measure resting swallow frequency using surface electromyography (sEMG).
Time Frame
Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment
Title
Change in Residual Mucosal Saliva (RMS)
Description
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
Title
Change in Amount of Saliva Produced
Description
Salivary flow rate (ml/minute) will be calculated under unstimulated and stimulated saliva collection conditions.
Time Frame
Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 65 years of age or older Dysphagia diagnosis based on videofluoroscopic swallow study with observed airway invasion (Penetration-Aspiration Scale score of 3 or higher) Ability to provide consent Ability to submit oral samples Ability to swallow sachet of probiotic (dissolved in thickened liquid, as needed) Ability to return to UWHC for week 2 and week 4 visits. Exclusion Criteria Currently taking antibiotics or probiotics Actively receiving immunosuppressive therapy Non-oral feeding with inability to swallow probiotic diagnosis of head and neck cancer or upper airway disease prior surgery to the head and neck region that would have affected the muscles of swallowing or the salivary glands history of chemotherapy or radiation to the head and neck region severe periodontal disease. currently pregnant or planning to become pregnant
Facility Information:
Facility Name
University of Wisconsin-Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53562
Country
United States

12. IPD Sharing Statement

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Impact of Probiotics on Oral Microbiota in Older Adults With Dysphagia

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