Impact of Probiotics on Oral Microbiota in Older Adults With Dysphagia

NCT03682094 | Completed Early Phase 1 FDA Drug

• 4 other identifiers: 2018-0428A534255SMPH/MEDICINE/GER-AD DEVProtocol Version 3/11/2019
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphagia

Keywords

probiotics; oral microbiome; dysphagia

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment

Secondary Outcomes (6)

• Eating Assessment Test (EAT-10)

  Baseline visit

• Functional Oral Intake Scale (FOIS) Score

  Baseline visit

• Kayser-Jones Brief Oral Health Status Examination (BOHSE)

  Baseline visit

• Change in Resting Swallow Frequency Rate

  Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment

• Change in Residual Mucosal Saliva (RMS)

  Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment

Study Arms (1)

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.

Drug: VSL#3

Interventions

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.

Also known as: probiotic

Probiotic

Eligibility Criteria

• Age: 65 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 53562, United States

Location

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: No masking.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: September 24, 2018
• Study Start: August 27, 2018
• Primary Completion: January 21, 2020
• Study Completion: January 21, 2020
• Last Updated: May 16, 2024

Record last verified: 2023-07

Locations

US (1)