Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-01-06 @ 4:23 PM
Study NCT ID:
NCT03682094
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2018-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Probiotics on Oral Microbiota in Older Adults With Dysphagia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No masking.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-13', 'studyFirstSubmitDate': '2018-08-21', 'studyFirstSubmitQcDate': '2018-09-21', 'lastUpdatePostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Oral microbiota profiles- bacterial diversity', 'timeFrame': 'Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Eating Assessment Test (EAT-10)', 'timeFrame': 'Baseline visit', 'description': 'Patient reported outcome measure for swallowing'}, {'measure': 'Functional Oral Intake Scale (FOIS) Score', 'timeFrame': 'Baseline visit', 'description': 'Scale used to quantify the amount of oral versus non-oral intake'}, {'measure': 'Kayser-Jones Brief Oral Health Status Examination (BOHSE)', 'timeFrame': 'Baseline visit', 'description': 'A valid and reliable scoring instrument developed for use with older adults by non-dental health care providers.'}, {'measure': 'Change in Resting Swallow Frequency Rate', 'timeFrame': 'Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment', 'description': 'We will measure resting swallow frequency using surface electromyography (sEMG).'}, {'measure': 'Change in Residual Mucosal Saliva (RMS)', 'timeFrame': 'Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment', 'description': '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'}, {'measure': 'Change in Amount of Saliva Produced', 'timeFrame': 'Baseline visit, 2 weeks post-enrollment, and 4 weeks post-enrollment', 'description': 'Salivary flow rate (ml/minute) will be calculated under unstimulated and stimulated saliva collection conditions.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['probiotics', 'oral microbiome', 'dysphagia'], 'conditions': ['Dysphagia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. 65 years of age or older\n2. Dysphagia diagnosis based on videofluoroscopic swallow study with observed airway invasion (Penetration-Aspiration Scale score of 3 or higher)\n3. Ability to provide consent\n4. Ability to submit oral samples\n5. Ability to swallow sachet of probiotic (dissolved in thickened liquid, as needed)\n6. Ability to return to UWHC for week 2 and week 4 visits.\n\nExclusion Criteria\n\n1. Currently taking antibiotics or probiotics\n2. Actively receiving immunosuppressive therapy\n3. Non-oral feeding with inability to swallow probiotic\n4. diagnosis of head and neck cancer or upper airway disease\n5. prior surgery to the head and neck region that would have affected the muscles of swallowing or the salivary glands\n6. history of chemotherapy or radiation to the head and neck region\n7. severe periodontal disease.\n8. currently pregnant or planning to become pregnant'}, 'identificationModule': {'nctId': 'NCT03682094', 'briefTitle': 'Impact of Probiotics on Oral Microbiota in Older Adults With Dysphagia', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Impact of Probiotics on Oral Microbiota in Older Adults With Dysphagia at Risk for Pneumonia', 'orgStudyIdInfo': {'id': '2018-0428'}, 'secondaryIdInfos': [{'id': 'A534255', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'SMPH/MEDICINE/GER-AD DEV', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'Protocol Version 3/11/2019', 'type': 'OTHER', 'domain': 'UW Madison'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotic', 'description': '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.', 'interventionNames': ['Drug: VSL#3']}], 'interventions': [{'name': 'VSL#3', 'type': 'DRUG', 'otherNames': ['probiotic'], 'description': '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.', 'armGroupLabels': ['Probiotic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53562', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin-Madison', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}