DysphagiaEarly Phase 1NCT03682094
Impact of Probiotics on Oral Microbiota in Older Adults With Dysphagia
A Early Phase 1 study testing VSL#3 in people with Dysphagia, run by University of Wisconsin, Madison at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 to 99 years
- Conditions the study is for
- Dysphagia
- What is being tested?
- VSL#3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2018to 21 Jan 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 99 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison
Madison, Wisconsin, 53562
About this study
Official title: 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.
Read the 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
- Being tested
- VSL#3
- Keywords
- probiotics, oral microbiome, dysphagia
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VSL#3Drug
Also called probiotic
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.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | 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. Receives: Drug: VSL#3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment
Secondary outcomes (6)
Eating Assessment Test (EAT-10)
Patient reported outcome measure for swallowing
Measured: Baseline visit
Functional Oral Intake Scale (FOIS) Score
Scale used to quantify the amount of oral versus non-oral intake
Measured: Baseline visit
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.
Measured: Baseline visit
Change in Resting Swallow Frequency Rate
We will measure resting swallow frequency using surface electromyography (sEMG).
Measured: Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment
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
Measured: Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment
Change in Amount of Saliva Produced
Salivary flow rate (ml/minute) will be calculated under unstimulated and stimulated saliva collection conditions.
Measured: Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start27 Aug 2018
- Primary completion21 Jan 2020
- Study completion21 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682094
- Sponsor's protocol ID
- 2018-0428
- Other IDs
- A534255, SMPH/MEDICINE/GER-AD DEV, Protocol Version 3/11/2019
- Status last verified
- Jul 2023
- First submitted
- 21 Aug 2018
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Probiotics on Oral Microbiota in Older Adults With Dysphagia at Risk for Pneumonia
- ClinicalTrials.gov ID
- NCT03682094
- Acronym / sponsor ID
- 2018-0428
- Conditions
- Dysphagia
- Keywords
- probiotics, oral microbiome, dysphagia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 27 Aug 2018 (actual)
- Primary completion
- 21 Jan 2020 (actual)
- Study completion
- 21 Jan 2020 (actual)
- First posted
- 24 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Drug: VSL#3The 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. |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VSL#3Also: probioticProbiotics 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. | Drug | Probiotic |
Primary outcome
Change in Oral microbiota profiles- bacterial diversity
Time frame: Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment
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).
6 secondary outcomes
Eating Assessment Test (EAT-10)
Time frame: Baseline visit
Functional Oral Intake Scale (FOIS) Score
Time frame: Baseline visit
Kayser-Jones Brief Oral Health Status Examination (BOHSE)
Time frame: Baseline visit
Change in Resting Swallow Frequency Rate
Time frame: Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment
Change in Residual Mucosal Saliva (RMS)
Time frame: Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment
Change in Amount of Saliva Produced
Time frame: Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
Related trials for Dysphagia
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Recruiting
taVNS in Infants Severe Dysphagia
Dysphagia, Swallowing Disorders
Not yet recruitingPhase 2
Early Feeding TL Trial
Total Laryngectomy
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing VSL#3 in people with Dysphagia, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oral microbiota profiles- bacterial diversity (time frame: Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.