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Parkinson DiseaseProbióticoNCT06019117

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

A study testing Probiotic K10 in people with Parkinson Disease and Alzheimer Disease, run by Deivis de Oliveira guimaraes at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Parkinson Disease, Alzheimer Disease
What is being tested?
Probiotic K10
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
104 participants
Where
1 siteBrazil
Study dates
10 Aug 2023to 7 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • 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
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  • 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

Who cannot join

  • 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.
Show all 27Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Gon1 gestora de Projetos

    Vitória, Espírito Santo, 29050335

Other trials in Brazil

About this study

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) 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.

Read the 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

Being tested
Probiotic K10, Placebo
Keywords
Probiotic, Alzheimer, Parkinson, Neurological desease
Medical subject headings
Parkinson Disease, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Probiotic K10Dietary supplement

    Also called Mix probiotic, Neurobiotic

    clinical trial using 90 days of probiotic K10

  • PlaceboDrug

    Also called flour

    clinical trial using 90 days of placebo controlled

Study groups in NCT06019117
Study groupRoleWhat they receive
Arm 1 - volunteers with parkinson's diseaseActive comparator26 patients in this arm. in this arm will receive the probiotic K10 (30.000.000 CFU/day).
Receives: Dietary Supplement: Probiotic K10
Arm 2 - volunteers with parkinson's diseasePlacebo comparator26 patients in this arm. In this arm will receive the controlled placebo.
Receives: Drug: Placebo
Arm 3- volunteers with alzheimer's diseaseActive comparator26 patients in this arm. in this arm will receive the probiotic K10 (30.000.000 CFU/day).
Receives: Dietary Supplement: Probiotic K10
Arm 4- volunteers with alzheimer's diseasePlacebo comparator26 patients in this arm. In this arm will receive the controlled placebo.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1st, 45 and 90 days

  2. 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.

    Measured: 1st, 45 and 90 days

  3. 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)

    Measured: 1st, 45 and 90 days

  4. Changes in cognitive status measured by brief battery (AD)

    Mini Mental State Examination (MMSE): maximum score 30 points. Higher values indicate greater cognitive performance.

    Measured: 1st, 45 and 90 days

  5. 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.

    Measured: 1st, 45 and 90 days

Secondary outcomes (1)

  1. 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.

    Measured: 1st, 45 and 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2023
  2. Study start10 Aug 2023
  3. Primary completion25 Nov 2023
  4. Study completion7 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Single-centre, double-blind, placebo-controlled randomized clinical trial (RCT), Interventional Model: Parallel Assignment, phase III study.
Masking
Single blind
Who is masked
Investigator
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06019117
Sponsor's protocol ID
2023001
Acronym
Probiótico
Status last verified
Jul 2025
First submitted
17 Aug 2023
Last updated
30 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Mazloom Z, Yousefinejad A, Dabbaghmanesh MH. Effect of probiotics on lipid profile, glycemic control, insulin action, oxidative stress, and inflammatory markers in patients with type 2 diabetes: a clinical trial. Iran J Med Sci. 2013 Mar;38(1):38-43.

    PubMed 23645956

  • Liu Z, Li T, Li P, Wei N, Zhao Z, Liang H, Ji X, Chen W, Xue M, Wei J. The Ambiguous Relationship of Oxidative Stress, Tau Hyperphosphorylation, and Autophagy Dysfunction in Alzheimer's Disease. Oxid Med Cell Longev. 2015;2015:352723. doi: 10.1155/2015/352723. Epub 2015 Jun 15.

    PubMed 26171115

  • Mishra V, Shah C, Mokashe N, Chavan R, Yadav H, Prajapati J. Probiotics as potential antioxidants: a systematic review. J Agric Food Chem. 2015 Apr 15;63(14):3615-26. doi: 10.1021/jf506326t. Epub 2015 Apr 6.

    PubMed 25808285

  • Licker V, Kovari E, Hochstrasser DF, Burkhard PR. Proteomics in human Parkinson's disease research. J Proteomics. 2009 Nov 2;73(1):10-29. doi: 10.1016/j.jprot.2009.07.007. Epub 2009 Jul 24.

    PubMed 19632367

  • Alexander GE, Crutcher MD, DeLong MR. Basal ganglia-thalamocortical circuits: parallel substrates for motor, oculomotor, "prefrontal" and "limbic" functions. Prog Brain Res. 1990;85:119-46.

    PubMed 2094891

  • Obeso JA, Rodriguez-Oroz MC, Chana P, Lera G, Rodriguez M, Olanow CW. The evolution and origin of motor complications in Parkinson's disease. Neurology. 2000;55(11 Suppl 4):S13-20; discussion S21-3.

    PubMed 11147505

  • Sood B, Patel P, Keenaghan M. Coenzyme Q10. 2024 Jan 30. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK531491/

    PubMed 30285386

  • Arenas-Jal M, Sune-Negre JM, Garcia-Montoya E. Coenzyme Q10 supplementation: Efficacy, safety, and formulation challenges. Compr Rev Food Sci Food Saf. 2020 Mar;19(2):574-594. doi: 10.1111/1541-4337.12539. Epub 2020 Feb 19.

    PubMed 33325173

  • Garrido-Maraver J, Cordero MD, Oropesa-Avila M, Vega AF, de la Mata M, Pavon AD, Alcocer-Gomez E, Calero CP, Paz MV, Alanis M, de Lavera I, Cotan D, Sanchez-Alcazar JA. Clinical applications of coenzyme Q10. Front Biosci (Landmark Ed). 2014 Jan 1;19(4):619-33. doi: 10.2741/4231.

    PubMed 24389208

  • Valentini L, Pinto A, Bourdel-Marchasson I, Ostan R, Brigidi P, Turroni S, Hrelia S, Hrelia P, Bereswill S, Fischer A, Leoncini E, Malaguti M, Blanc-Bisson C, Durrieu J, Spazzafumo L, Buccolini F, Pryen F, Donini LM, Franceschi C, Lochs H. Impact of personalized diet and probiotic supplementation on inflammation, nutritional parameters and intestinal microbiota - The "RISTOMED project": Randomized controlled trial in healthy older people. Clin Nutr. 2015 Aug;34(4):593-602. doi: 10.1016/j.clnu.2014.09.023. Epub 2014 Oct 8.

    PubMed 25453395

  • Padurariu M, Ciobica A, Lefter R, Serban IL, Stefanescu C, Chirita R. The oxidative stress hypothesis in Alzheimer's disease. Psychiatr Danub. 2013 Dec;25(4):401-9.

    PubMed 24247053

  • Blum D, Torch S, Lambeng N, Nissou M, Benabid AL, Sadoul R, Verna JM. Molecular pathways involved in the neurotoxicity of 6-OHDA, dopamine and MPTP: contribution to the apoptotic theory in Parkinson's disease. Prog Neurobiol. 2001 Oct;65(2):135-72. doi: 10.1016/s0301-0082(01)00003-x.

    PubMed 11403877

Questions about this trial

What is this clinical trial studying?

A study testing Probiotic K10 in people with Parkinson Disease and Alzheimer Disease, run by Deivis de Oliveira guimaraes at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in MDS-Unified (PD) (time frame: 1st, 45 and 90 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06019117, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.

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