- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03682094
Impact of Probiotics on Oral Microbiota in Older Adults With Dysphagia
July 28, 2023 updated by: University of Wisconsin, Madison
Impact of Probiotics on Oral Microbiota in Older Adults With Dysphagia at Risk for Pneumonia
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Wisconsin
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Madison, Wisconsin, United States, 53562
- University of Wisconsin-Madison
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
63 years to 97 years (Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Oral microbiota profiles- bacterial diversity
Time Frame: Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment
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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).
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Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eating Assessment Test (EAT-10)
Time Frame: Baseline visit
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Patient reported outcome measure for swallowing
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Baseline visit
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Functional Oral Intake Scale (FOIS) Score
Time Frame: Baseline visit
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Scale used to quantify the amount of oral versus non-oral intake
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Baseline visit
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Kayser-Jones Brief Oral Health Status Examination (BOHSE)
Time Frame: Baseline visit
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A valid and reliable scoring instrument developed for use with older adults by non-dental health care providers.
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Baseline visit
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Change in Resting Swallow Frequency Rate
Time Frame: Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment
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We will measure resting swallow frequency using surface electromyography (sEMG).
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Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment
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Change in Residual Mucosal Saliva (RMS)
Time Frame: Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment
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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
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Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment
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Change in Amount of Saliva Produced
Time Frame: Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment
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Salivary flow rate (ml/minute) will be calculated under unstimulated and stimulated saliva collection conditions.
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Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 13, 2018
Primary Completion (Estimated)
March 1, 2024
Study Completion (Estimated)
March 1, 2024
Study Registration Dates
First Submitted
August 21, 2018
First Submitted That Met QC Criteria
September 21, 2018
First Posted (Actual)
September 24, 2018
Study Record Updates
Last Update Posted (Actual)
August 1, 2023
Last Update Submitted That Met QC Criteria
July 28, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-0428
- A534255 (Other Identifier: UW Madison)
- SMPH/MEDICINE/GER-AD DEV (Other Identifier: UW Madison)
- Protocol Version 3/11/2019 (Other Identifier: UW Madison)
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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