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Completed

NCT Number: NCT03682094

Impact of Probiotics on Oral Microbiota in Older Adults With Dysphagia

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.

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Key information

Conditions

Dysphagia Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

65 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Wisconsin-Madison

Madison, Wisconsin, 53562, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VSL#3

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.

Other names: probiotic

Primary outcomes

  1. 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).

Secondary outcomes

  1. Eating Assessment Test (EAT-10)

    Time frame: Baseline visit

    Patient reported outcome measure for swallowing

  2. Functional Oral Intake Scale (FOIS) Score

    Time frame: Baseline visit

    Scale used to quantify the amount of oral versus non-oral intake

  3. Kayser-Jones Brief Oral Health Status Examination (BOHSE)

    Time frame: Baseline visit

    A valid and reliable scoring instrument developed for use with older adults by non-dental health care providers.

  4. Change in Resting Swallow Frequency Rate

    Time frame: Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment

    We will measure resting swallow frequency using surface electromyography (sEMG).

  5. Change in Residual Mucosal Saliva (RMS)

    Time frame: Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment

    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

  6. Change in Amount of Saliva Produced

    Time frame: Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment

    Salivary flow rate (ml/minute) will be calculated under unstimulated and stimulated saliva collection conditions.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 24, 2018
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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