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

Primary Purpose

Parkinson Disease, Alzheimer Disease

Status
Active
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Probiotic K10
Placebo
Sponsored by
Deivis de Oliveira guimaraes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson Disease focused on measuring Probiotic, Alzheimer, Parkinson, Neurological desease

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Gon1 gestora de Projetos

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

Arm 1 - volunteers with parkinson's disease

Arm 2 - volunteers with parkinson's disease

Arm 3- volunteers with alzheimer's disease

Arm 4- volunteers with alzheimer's disease

Arm Description

26 patients in this arm. in this arm will receive the probiotic K10 (2mg/kg/dia).

26 patients in this arm. In this arm will receive the controlled placebo.

26 patients in this arm. in this arm will receive the probiotic K10 (2mg/kg/dia).

26 patients in this arm. In this arm will receive the controlled placebo.

Outcomes

Primary Outcome Measures

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.
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.
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)
Changes in cognitive status measured by brief battery (AD)
Mini Mental State Examination (MMSE): maximum score 30 points. Higher values indicate greater cognitive performance.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 17, 2023
Last Updated
August 24, 2023
Sponsor
Deivis de Oliveira guimaraes
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1. Study Identification

Unique Protocol Identification Number
NCT06019117
Brief Title
Effectiveness of Probiotic K10 in Managing Health Outcomes in Parkinson and Alzheimer Disease
Acronym
Probiótic
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 10, 2023 (Actual)
Primary Completion Date
December 11, 2023 (Anticipated)
Study Completion Date
December 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Deivis de Oliveira guimaraes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Alzheimer Disease
Keywords
Probiotic, Alzheimer, Parkinson, Neurological desease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-centre, double-blind, placebo-controlled randomized clinical trial (RCT), Interventional Model: Parallel Assignment, phase III study.
Masking
Investigator
Allocation
Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 - volunteers with parkinson's disease
Arm Type
Active Comparator
Arm Description
26 patients in this arm. in this arm will receive the probiotic K10 (2mg/kg/dia).
Arm Title
Arm 2 - volunteers with parkinson's disease
Arm Type
Placebo Comparator
Arm Description
26 patients in this arm. In this arm will receive the controlled placebo.
Arm Title
Arm 3- volunteers with alzheimer's disease
Arm Type
Active Comparator
Arm Description
26 patients in this arm. in this arm will receive the probiotic K10 (2mg/kg/dia).
Arm Title
Arm 4- volunteers with alzheimer's disease
Arm Type
Placebo Comparator
Arm Description
26 patients in this arm. In this arm will receive the controlled placebo.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic K10
Other Intervention Name(s)
Cerenovex, Neurobiotic
Intervention Description
clinical trial using 90 days of probiotic K10
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
flour
Intervention Description
clinical trial using 90 days of placebo controlled
Primary Outcome Measure Information:
Title
Change in MDS-Unified (PD)
Description
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
Title
Change in quality of life scale (PD)
Description
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
Title
Changes in anxiety levels (PD&AD)
Description
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
Title
Changes in cognitive status measured by brief battery (AD)
Description
Mini Mental State Examination (MMSE): maximum score 30 points. Higher values indicate greater cognitive performance.
Time Frame
1st, 45 and 90 days
Title
Change in Quality of Life (QOL) (AD)
Description
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
Secondary Outcome Measure Information:
Title
Change in cortisol dosage (Parkinson's and Alzheimer's group)
Description
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

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Parkinson under 18 years. Alzheimer between 60 and 85 years
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alyne M Ton, post-doc
Organizational Affiliation
Gon1 Gestora de Projetos
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roberto S Badaró, post-doc
Organizational Affiliation
SENAI CIMATEC
Official's Role
Study Director
Facility Information:
Facility Name
Gon1 gestora de Projetos
City
Vitória
State/Province
ES
ZIP/Postal Code
29050335
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We can share all data regarding data collection, preserving the personal data of volunteers and as long as the request does not go beyond the limits of confidentiality, integrity and ethics.
IPD Sharing Time Frame
They will be available after data collection and analysis, and will be abble for 1 year after the trial end.
IPD Sharing Access Criteria
will be available upon request and for exclusive access to scientists, governmental and scientific organizations.
IPD Sharing URL
http://www.gon1.com.br/ipd
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Effectiveness of Probiotic K10 in Managing Health Outcomes in Parkinson and Alzheimer Disease

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