Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT03682094
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Maximum Age:
99 Years
Study:
NCT03682094
Study Brief:
Protocol Section:
NCT03682094