Effectiveness of Probiotic K10 in Managing Health Outcomes in Parkinson and Alzheimer Disease
NCT ID: NCT06019117
Last Updated: 2025-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
104 participants
INTERVENTIONAL
2023-08-10
2024-01-07
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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).
Probiotic K10
clinical trial using 90 days of probiotic K10
Arm 2 - volunteers with parkinson's disease
26 patients in this arm. In this arm will receive the controlled placebo.
Placebo
clinical trial using 90 days of placebo controlled
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).
Probiotic K10
clinical trial using 90 days of probiotic K10
Arm 4- volunteers with alzheimer's disease
26 patients in this arm. In this arm will receive the controlled placebo.
Placebo
clinical trial using 90 days of placebo controlled
Interventions
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Probiotic K10
clinical trial using 90 days of probiotic K10
Placebo
clinical trial using 90 days of placebo controlled
Other Intervention Names
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Eligibility Criteria
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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
* 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
* 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.
* 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.
18 Years
85 Years
ALL
No
Sponsors
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Deivis de Oliveira guimaraes
NETWORK
Responsible Party
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Deivis de Oliveira guimaraes
Director of Research
Principal Investigators
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Alyne M Ton, post-doc
Role: PRINCIPAL_INVESTIGATOR
Gon1 Gestora de Projetos
Sarha A L Queiroz, PhD
Role: PRINCIPAL_INVESTIGATOR
Gon1 Gestora de Projetos
Deivis O Guimaraes, Mba
Role: STUDY_DIRECTOR
Gon1 Gestora de Projetos
Locations
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Gon1 gestora de Projetos
Vitória, Espírito Santo, Brazil
Countries
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References
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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.
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.
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.
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.
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.
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.
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/
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.
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.
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.
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.
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.
Other Identifiers
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2023001
Identifier Type: -
Identifier Source: org_study_id
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