Probiótic: Effectiveness of Probiotic K10 in Managing Health Outcomes in Parkinson and Alzheimer Disease

Sponsor

Deivis de Oliveira guimaraes (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06019117

Collaborator

(none)

104

Enrollment

Location

Arms

4.3

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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 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 2 ml/kg/day). They will be evaluated at baseline, 45 days and 90 days.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease Alzheimer Disease	Dietary Supplement: Probiotic K10 Drug: Placebo	N/A

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 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 Design

Study Type:

Interventional

Anticipated Enrollment :

104 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Single-centre, double-blind, placebo-controlled randomized clinical trial (RCT), Interventional Model: Parallel Assignment, phase III study.Single-centre, double-blind, placebo-controlled randomized clinical trial (RCT), Interventional Model: Parallel Assignment, phase III study.

Masking:

Single (Investigator)

Primary Purpose:

Supportive Care

Official Title:

Effectiveness of a Probiotic K10 in Managing Health Outcomes in Parkinson's Disease and in Early Stage (Mild Cognitive Impairment to Mild Dementia) Alzheimer's Disease

Actual Study Start Date :

Aug 10, 2023

Anticipated Primary Completion Date :

Dec 11, 2023

Anticipated Study Completion Date :

Dec 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm 1 - volunteers with parkinson's disease 26 patients in this arm. in this arm will receive the probiotic K10 (2mg/kg/dia).	Dietary Supplement: Probiotic K10 clinical trial using 90 days of probiotic K10 Other Names: Cerenovex Neurobiotic
Placebo Comparator: Arm 2 - volunteers with parkinson's disease 26 patients in this arm. In this arm will receive the controlled placebo.	Drug: Placebo clinical trial using 90 days of placebo controlled Other Names: flour
Active Comparator: Arm 3- volunteers with alzheimer's disease 26 patients in this arm. in this arm will receive the probiotic K10 (2mg/kg/dia).	Dietary Supplement: Probiotic K10 clinical trial using 90 days of probiotic K10 Other Names: Cerenovex Neurobiotic
Placebo Comparator: Arm 4- volunteers with alzheimer's disease 26 patients in this arm. In this arm will receive the controlled placebo.	Drug: Placebo clinical trial using 90 days of placebo controlled Other Names: flour

Outcome Measures

Primary Outcome Measures

Change in MDS-Unified (PD) [1st, 45 and 90 days]
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.
Change in quality of life scale (PD) [1st, 45 and 90 days]
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.
Changes in anxiety levels (PD&AD) [1st, 45 and 90 days]
Changes in anxiety levels, mood improvement and caregiver burden will be determined by applying the Neuropsychiatric Questionnaire (NPI-Q)
Changes in cognitive status measured by brief battery (AD) [1st, 45 and 90 days]
Mini Mental State Examination (MMSE): maximum score 30 points. Higher values indicate greater cognitive performance.
Change in Quality of Life (QOL) (AD) [1st, 45 and 90 days]
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.

Secondary Outcome Measures

Change in cortisol dosage (Parkinson's and Alzheimer's group) [1st, 45 and 90 days]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

Parkinson's Exclusion Criteria:

Parkinsonism due to drugs including neuroleptics, alpha-methyldopa, reserpine, metoclopramide, valproic acid.
Use of antioxidants (such as selegiline, rasagiline, vitamins E and C), additional supplemental vitamins or minerals, regular use of neuroleptics, chloramphenicol, valproic acid, warfarin.
Other parkinsonian disorders.
Modified Hoehn and Yahr score of 3 or more on Screening Visit or Baseline Visit.
UPDRS tremor score of 3 or greater at Screening Visit or Baseline Visit.
History of symptomatic stroke.
Sufficient deficiency to require changes in dopaminergic medication treatment during follow-up compared to baseline treatment schedule.
Other severe and uncompensated illnesses, including severe psychiatric illnesses.
Patients with active cardiovascular, restrictive peripheral vascular, or cerebrovascular disease in the past year.
Unstable dose of active CNS therapies.
Use of appetite suppressants within 60 days of the Baseline Visit.
History of active epilepsy within the past 5 years.
Participation in other drug studies or use of other investigational drugs within 30 days prior to the Screening Visit.
History of electroconvulsive therapy.
History of any brain surgery for Parkinson's disease.
History of structural brain disease, such as previous trauma causing damage detected on a CT scan or MRI, hydrocephalus, or previous brain neoplasms.

Alzheimer's Exclusion Criteria:

Significant neurological disease such as Parkinson's disease, stroke, brain tumor, multiple sclerosis, or seizure disorder
Major depression treated in the past 12 months, major mental illness such as schizophrenia, or recent (in past 12 months) alcohol or substance abuse
History of invasive cancer within the past two years (excluding non-melanoma skin cancer)
Use of any investigational agents within 30 days prior to screening
Major surgery within 8 weeks prior to the Baseline Visit
Uncontrolled cardiac conditions or severe unstable medical illnesses
Antiretroviral therapy for human immunodeficiency virus (HIV)
Conditions that will contribute to oxidative stress: current cigarette or cigar smokers (within past month), diabetics on insulin or poorly controlled on oral hypoglycemics
Blindness, deafness, language difficulties or any other disability which may prevent the participant from participating or cooperating in the protocol.