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 evaluation. Single-centre, double-blind, placebo-controlled randomized clinical trial (RCT), Interventional Model: Parallel Assignment, phase III study. Two groups will be composed, with two arms each, 1 group composed of patients with Parkinson's and 1 group with patients with Alzheimer's, 52 patients in each group. The first arm of each group will receive placebo and the other arm of each group will receive the mix K10. In this study, researchers will conduct a randomized, placebo-controlled, phase III trial of a probiotic preparation (Probiotic K10) to evaluate its use as a viable treatment option for neurodegenerative disorders, including Parkinson's disease (PD) and Alzheimer's disease. of Alzheimer (AD). This formulation has been previously demonstrated to improve cognitive function, systemic inflammation, systemic oxidative stress in Alzheimer's patients. The main objective of this study is to compare its effect with placebo on cognitive status in individuals with AD and PD, the UPDRS total score in people with early PD and quality of life, and the measurement of caregiver burden in AD and PD. Participants will be randomly assigned to receive a placebo (an inactive substance) and a K10 probiotic (dose 30.000.000 CFU/day). They will be evaluated at baseline, 45 days and 90 days.
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 and reduced inflammatory damage. Baseline to T90 or the time of sufficient disability to study closure. All measurements will be taken at time zero (start of the survey), the next measurement in 45 days and the last measurement in 90 days. We will use the comparison of the data collected from each individual at time zero in comparison with their own results collected at the next times, using biostatistics to compare the results and, at the end of the primary result, we will perform the simple tabulation to count the values of each analyzed variable. Differences between measures of central tendency with pr \< 0.05 will be considered statistically significant. When the central tendency values present a normal distribution in the statistical test, a parametric test will be used. In the case of comparison of 2 means, Student's t test will be used, for paired or independent samples. When the comparison includes more than 2 means, analysis of variance (ANOVA) will be used for 1 way (a single factor, e.g. treatment time) or 2 ways (two factors, for example treatment time and control group x treated group ). After verifying a significant difference in ANOVA, a post hoc protected t-test will then be applied to detect at which points in the analysis there are pairs with significant differences. When the analysis of the distribution (frequency) of the data shows a distribution that is not compatible with the Gaussian distribution, a corresponding non-parametric test will be used. Contingency tables 2 x 2 will also be used for later calculation of risk factors and to determine the significance through the X2 test. The software to be used will be Prism from Graphpad v. 9
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
104
clinical trial using 90 days of probiotic K10
clinical trial using 90 days of placebo controlled
Gon1 gestora de Projetos
Vitória, Espírito Santo, Brazil
Change in MDS-Unified (PD)
scale (MDS- UPDRS) the sum of parts I, II and III ranges from 0 to 176. The MDS-UPDRS score has three components, each consisting of questions with 0-4 point scale. Part I assesses mentation, behavior, and mood; Part II assesses activities of daily; and Part III assesses motor abilities. Where 0 represents the absence of impairment and 4 represents the highest degree of impairment.
Time frame: 1st, 45 and 90 days
Change in quality of life scale (PD)
Questionnaire (PDQ-39) that will evaluate their health and overall quality of life. The total of 39 aspects of quality of life, maximum score is 132. Each aspect is rated on scale of 0 (best outcome) to 4 (worst outcome). A higher score or increased score compared to a previous visit indicates a lowered quality of life.
Time frame: 1st, 45 and 90 days
Changes in anxiety levels (PD&AD)
Changes in anxiety levels, mood improvement and caregiver burden will be determined by applying the Neuropsychiatric Questionnaire (NPI-Q)
Time frame: 1st, 45 and 90 days
Changes in cognitive status measured by brief battery (AD)
Mini Mental State Examination (MMSE): maximum score 30 points. Higher values indicate greater cognitive performance.
Time frame: 1st, 45 and 90 days
Change in Quality of Life (QOL) (AD)
13-item QOL-AD scale (total score range 13-52; higher scores indicate better QOL). The QOL-AD scale uses 1-4 (poor, fair, good, or excellent) to rate a variety of life domains, including the patient's physical health, mood, relationships, activities, and ability to complete tasks.
Time frame: 1st, 45 and 90 days
Change in cortisol dosage (Parkinson's and Alzheimer's group)
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 and reduced inflammatory damage.
Time frame: 1st, 45 and 90 days
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