Impact of Probiotics on Oral Microbiota in Older Adults With Dysphagia



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:65 - 99
Updated:9/26/2018
Start Date:August 13, 2018
End Date:August 31, 2019
Contact:Nicole Pulia, PhD
Email:npulia@wisc.edu
Phone:6082561901

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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.

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.

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
We found this trial at
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Madison, Wisconsin 53706
(608) 263-2400
Principal Investigator: Nicole Pulia, PhD
Phone: 708-699-8615
University of Wisconsin-Madison In achievement and prestige, the University of Wisconsin-Madison has long been recognized...
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