Clinical trial

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

NCT03682094

Name

2018-0428

Description

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.

Trial arms

Trial start

2018-08-27

Estimated PCD

2020-01-21

Trial end

2020-01-21

Status

Completed

Phase

Early phase I

Treatment

VSL#3

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.

Arms:

Probiotic

Other names:

probiotic

Size

Primary endpoint

Change in Oral microbiota profiles- bacterial diversity

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

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No masking.'}}, 'enrollmentInfo': {'count': 9, 'type': 'ACTUAL'}}

Updated at

2024-05-16

1 organization

1 product

1 indication

Organization

University of Wisconsin, Madison

Product

VSL#3

Indication

Difficulty swallowing