Status:
COMPLETED
Effectiveness of Probiotic K10 in Managing Health Outcomes in Parkinson and Alzheimer Disease
Lead Sponsor:
Deivis de Oliveira guimaraes
Conditions:
Parkinson Disease
Alzheimer Disease
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Evaluation of the effects of the K10 probiotic mix in patients with degenerative neurological diseases (Parkinson and Alzheimer's) with a focus on cognitive, motor and psychiatric neurological evaluat...
Detailed Description
Change in urinary cortisol dosage Determination of cortisol levels can be used as an indirect measurement of emotional stress. Reduced levels of this hormone are related to reduced cardiovascular risk...
Eligibility Criteria
Inclusion
- Eligibility criteria for individuals with Parkinson's. Ages eligible to participate in the study: 18 years or older Accept healthy volunteers: No. Gender Eligibility for Study: All genders
- Inclusion criteria:
- Presence of all 3 cardinal features of Parkinson's disease (tooth tremor, bradykinesia, and rigidity). Clinical signs must be asymmetrical.
- Diagnosis of Parkinson's disease within 5 years of the Screening Visit.
- Age 18 years or older.
- Women must not be of childbearing potential or must use an approved form of contraception during the trial period.
- Eligibility Criteria for Individuals with Alzheimer's. Eligible ages to participate in the study: 60 -85 years Accept healthy volunteers: No. Gender Eligibility for Study: All genders
- Inclusion criteria:
- Men or women between the ages of 60 and 85
- Diagnosis of probable Alzheimer's disease
- Portuguese-speaking, English-speaking; Spanish-speaking if the individual site allows
- Study partner or caregiver to ensure compliance
- Mini-Mental State Exam score at screening visit greater than 14
- Stable medical condition for 3 months prior to screening, with no significant abnormal liver, kidney, or blood studies.
- Able to take oral medications
- Modified Hachinski Ischemic Index less than or equal to 4
- CT or MRI from the onset of memory impairment, demonstrating the absence of a clinically significant focal lesion
- Physically acceptable for this study, as confirmed by medical history, physical examination, neurological examination, and clinical testing
Exclusion
- Parkinson's
Key Trial Info
Start Date :
August 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 7 2024
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT06019117
Start Date
August 10 2023
End Date
January 7 2024
Last Update
July 30 2025
Active Locations (1)
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1
Gon1 gestora de Projetos
Vitória, Espírito Santo, Brazil, 29050335