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

July 27, 2025 updated by: Deivis de Oliveira guimaraes

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • ES
      • Vitória, ES, Brazil, 29050335
        • Gon1 gestora de Projetos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
Active Comparator: Arm 1 - volunteers with parkinson's disease
26 patients in this arm. in this arm will receive the probiotic K10 (30.000.000 CFU/day).
Dietary supplement: Probiotic K10
clinical trial using 90 days of probiotic K10
Other Names:
  • Neurobiotic
  • Mix probiotic
Active Comparator: Arm 3- volunteers with alzheimer's disease
26 patients in this arm. in this arm will receive the probiotic K10 (30.000.000 CFU/day).
Dietary supplement: Probiotic K10
clinical trial using 90 days of probiotic K10
Other Names:
  • Neurobiotic
  • Mix probiotic

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cortisol dosage (Parkinson's and Alzheimer's group)
Time Frame: 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.
1st, 45 and 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deivis de Oliveira guimaraes

Investigators

  • Principal Investigator: Alyne M Ton, post-doc, Gon1 gestora de Projetos
  • Principal Investigator: Sarha A L Queiroz, PhD, Gon1 gestora de Projetos
  • Study Director: Deivis O Guimaraes, Mba, Gon1 gestora de Projetos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2023

Primary Completion (Actual)

November 25, 2023

Study Completion (Actual)

January 7, 2024

Study Registration Dates

First Submitted

August 17, 2023

First Submitted That Met QC Criteria

August 24, 2023

First Posted (Actual)

August 31, 2023

Study Record Updates

Last Update Posted (Actual)

July 30, 2025

Last Update Submitted That Met QC Criteria

July 27, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023001 (SUN Yat-sen University)
  • 13536327 (Registry Identifier: ISRCTN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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