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

NCT06019117 | Completed

• 1 other identifier: 2023001
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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 30.000.000 CFU/day). They will be evaluated at baseline, 45 days and 90 days.

Conditions

Parkinson Disease; Alzheimer Disease

Keywords

Probiotic; Alzheimer; Parkinson; Neurological desease

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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)

  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.

  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.

  1st, 45 and 90 days

Secondary Outcomes (1)

• Change in cortisol dosage (Parkinson's and Alzheimer's group)

  1st, 45 and 90 days

Study Arms (4)

Arm 1 - volunteers with parkinson's disease

ACTIVE COMPARATOR

26 patients in this arm. in this arm will receive the probiotic K10 (30.000.000 CFU/day).

Dietary Supplement: Probiotic K10

Arm 2 - volunteers with parkinson's disease

PLACEBO COMPARATOR

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

Drug: Placebo

Arm 3- volunteers with alzheimer's disease

ACTIVE COMPARATOR

26 patients in this arm. in this arm will receive the probiotic K10 (30.000.000 CFU/day).

Dietary Supplement: Probiotic K10

Arm 4- volunteers with alzheimer's disease

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Probiotic K10 DIETARY_SUPPLEMENT

clinical trial using 90 days of probiotic K10

Also known as: Mix probiotic, Neurobiotic

Arm 1 - volunteers with parkinson's disease; Arm 3- volunteers with alzheimer's disease

Placebo DRUG

clinical trial using 90 days of placebo controlled

Also known as: flour

Arm 2 - volunteers with parkinson's disease; Arm 4- volunteers with alzheimer's disease

Eligibility Criteria

• Age: 18 Years - 85 Years
• Gender Eligibility Details: Parkinson under 18 years. Alzheimer between 60 and 85 years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Deivis de Oliveira guimaraes: lead

Study Sites (1)

Gon1 gestora de Projetos

Vitória, Espírito Santo, 29050335, Brazil

Location

Related Publications (12)

• 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.

  PMID: 23645956 BACKGROUND

• 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.

  PMID: 26171115 BACKGROUND

• 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.

  PMID: 25808285 BACKGROUND

• 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.

  PMID: 19632367 BACKGROUND

• 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.

  PMID: 2094891 BACKGROUND

• 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.

  PMID: 11147505 BACKGROUND

• Sood B, Patel P, Keenaghan M. Coenzyme Q10. 2024 Jan 30. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK531491/

  PMID: 30285386 BACKGROUND

• 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.

  PMID: 33325173 BACKGROUND

• 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.

  PMID: 24389208 BACKGROUND

• 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.

  PMID: 25453395 RESULT

• 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.

  PMID: 24247053 RESULT

• 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.

  PMID: 11403877 RESULT

MeSH Terms

Conditions

Parkinson Disease; Alzheimer Disease

Interventions

Flour

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dementia; Tauopathies; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Alyne M Ton, post-doc

  Gon1 Gestora de Projetos

  PRINCIPAL INVESTIGATOR

• Sarha A L Queiroz, PhD

  Gon1 Gestora de Projetos

  PRINCIPAL INVESTIGATOR

• Deivis O Guimaraes, Mba

  Gon1 Gestora de Projetos

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Research

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

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 31, 2023
• Study Start: August 10, 2023
• Primary Completion: November 25, 2023
• Study Completion: January 7, 2024
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: They will be available after data collection and analysis, and will be abble for 1 year after the trial end.
• Access Criteria: will be available upon request and for exclusive access to scientists, governmental and scientific organizations.

Locations

BR (1)