Effectiveness of probiotic K10 in managing health outcomes in Parkinson's and Alzheimer's disease
| ISRCTN | ISRCTN13536327 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13536327 |
| Secondary identifying numbers | 202301 |
- Submission date
- 19/08/2023
- Registration date
- 22/08/2023
- Last edited
- 28/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
We developed a clinical trial prior to this one, where we used the probiotic K10 in patients with Alzheimer's disease and obtained excellent results, so we decided to expand the number of patients in a new study, and also include another neurological disease, in this case Parkinson’s disease.
Who can participate?
Adult patients with Parkinson's or Alzheimer's disease.
What does the study involve?
This clinical trial will have 4 arms, being divided into two groups, group 1 with Alzheimer's and group 2 with Parkinson's, one arm of each group will receive probiotic K10 and one arm of each group will receive a controlled placebo.
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 (30,000,000 CFU/day). They will be evaluated at baseline, 45 days and 90 days.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Gon1 gestora de projetos (Brazil)
When is the study starting and how long is it expected to run for?
July 2023 to December 2023
Who is funding the study?
1. Micillic Ltd. (Portugal)
2. Gon1 Gestora de Projetos Ltda (Brazil)
Who is the main contact?
Deivis Oliveira Guimaraes
deivis.guimaraes@gon1.com.br
Contact information
Public
Avenida Nossa senhora dos navegantes, 955
sala 719
Vitória
29050335
Brazil
 ORCID ID |
0009-0003-8970-5778 |
|---|---|
| Phone | +55 027 999429900 |
| Deivis.guimaraes@gon1.com.br |
Principal Investigator
Avenida Nossa senhora dos navegantes, 955
sala 719
Vitória
29050335
Brazil
| ORCID ID |
0000-0002-0128-2746 |
|---|---|
| Phone | +55 027 98134-7065 |
| lyne_msv@hotmail.com |
Study information
| Study design | Single-centre double-blind placebo-controlled randomized parallel trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | University/medical school/dental school, Workplace |
| Study type | Treatment, Efficacy |
| Participant information sheet | No participant information sheet available |
| Scientific 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 acronym | K10 PK & AD |
| Study objectives | Evaluation of the effects of the K10 probiotic mix in patients with degenerative neurological diseases (Parkinson's and Alzheimer's) with a focus on cognitive, motor and psychiatric neurological evaluation. |
| Ethics approval(s) |
Approved 27/07/2023, Universidade Vila Velha - ES/UVV (Avenida Comissário José Dantas de Melo, 21, Vila Velha, 29102-920, Brazil; +55 (27) 3421-2063; cep@uvv.br), ref: 6.202.959 |
| Health condition(s) or problem(s) studied | Improvement of symptoms in patients with Parkinson's and Alzheimer's disease |
| Intervention | 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 (30,000,000 CFU/day). They will be evaluated at baseline, 45 days and 90 days. Randomization using an online tool: https://ctrandomization.cancer.gov/tool/ |
| Intervention type | Supplement |
| Primary outcome measure | 1. Parkinson's group 1.1. Parkinson's Disease rating scale (MDS- UPDRS) at baseline visit, 45 days and 90 days or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first. 1.2. PD quality of life scale (PDQ-39) at baseline visit, 45 days and 90 days or the time of sufficient disability to require dopaminergic therapy or study closure. 1.3. Anxiety levels, mood and caregiver burden in neuropsychiatric evaluation from baseline to T90 or the time of sufficient disability to require dopaminergic therapy or study closure. 2. Alzheimer's group 2.1. Cognitive status measured by brief battery focused on evaluating memory, visuo-spatial skills, constructive skills, language, praxys and attention. at baseline visit, 45 days and 90 days. 2.2. DA Quality of Life Scale baseline visit, 45 days and 90 days. 2.3. Anxiety levels, mood and caregiver burden in neuropsychiatric evaluation from baseline to T90 or the time of sufficient disability to require dopaminergic therapy or study closure. |
| Secondary outcome measures | Indirect measurement of emotional stress measured by urinary cortisol dosage at baseline visit, 45 days and 90 days. |
| Overall study start date | 27/07/2023 |
| Completion date | 11/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 85 Years |
| Sex | Both |
| Target number of participants | 104 |
| Total final enrolment | 166 |
| Key inclusion criteria | Parkinson's arm 1. Presence of all 3 cardinal features of Parkinson's disease (tooth tremor, bradykinesia, and rigidity). Clinical signs must be asymmetrical. 2. Diagnosis of Parkinson's disease within 5 years of the Screening Visit. 3. Age 18 years or older. 4. Women must not be of childbearing potential or must use an approved form of contraception during the trial period. Alzheimer's arm 1. Men or women between the ages of 60 and 85 2. Diagnosis of probable Alzheimer's disease 3. Portuguese-speaking, English-speaking; Spanish-speaking if the individual site allows 4. Study partner or caregiver to ensure compliance 5. Mini-Mental State Exam score at screening visit greater than 14 6. Stable medical condition for 3 months prior to screening, with no significant abnormal liver, kidney, or blood studies. 7. Able to take oral medications 8. Modified Hachinski Ischemic Index less than or equal to 4 9. CT or MRI from the onset of memory impairment, demonstrating the absence of a clinically significant focal lesion 10. Physically acceptable for this study, as confirmed by medical history, physical examination, neurological examination, and clinical testing |
| Key exclusion criteria | Parkinson's arm: 1. Parkinsonism due to drugs including neuroleptics, alpha-methyldopa, reserpine, metoclopramide, valproic acid. 2. Use of antioxidants (such as selegiline, rasagiline, vitamins E and C), additional supplemental vitamins or minerals, regular use of neuroleptics, chloramphenicol, valproic acid, warfarin. 3. Other parkinsonian disorders. 4. Modified Hoehn and Yahr score of 3 or more on Screening Visit or Baseline Visit. 5. UPDRS tremor score of 3 or greater at Screening Visit or Baseline Visit. 6. History of symptomatic stroke. 7. Sufficient deficiency to require changes in dopaminergic medication treatment during follow-up compared to baseline treatment schedule. 8. Other severe and uncompensated illnesses, including severe psychiatric illnesses. 9. Patients with active cardiovascular, restrictive peripheral vascular, or cerebrovascular disease in the past year. 10. Unstable dose of active CNS therapies. 11. Use of appetite suppressants within 60 days of the Baseline Visit. 12. History of active epilepsy within the past 5 years. 13. Participation in other drug studies or use of other investigational drugs within 30 days prior to the Screening Visit. 14. History of electroconvulsive therapy. 15. History of any brain surgery for Parkinson's disease. 16. 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 arm: 1. Significant neurological disease such as Parkinson's disease, stroke, brain tumor, multiple sclerosis, or seizure disorder 2. Major depression treated in the past 12 months, major mental illness such as schizophrenia, or recent (in past 12 months) alcohol or substance abuse 3. History of invasive cancer within the past two years (excluding non-melanoma skin cancer) 4. Use of any investigational agents within 30 days prior to screening 5. Major surgery within 8 weeks prior to the Baseline Visit 6. Uncontrolled cardiac conditions or severe unstable medical illnesses 7. Antiretroviral therapy for human immunodeficiency virus (HIV) 8. Conditions that will contribute to oxidative stress: current cigarette or cigar smokers (within past month), diabetics on insulin or poorly controlled on oral hypoglycemics 9. Blindness, deafness, language difficulties or any other disability which may prevent the participant from participating or cooperating in the protocol. |
| Date of first enrolment | 28/07/2023 |
| Date of final enrolment | 10/08/2023 |
Locations
Countries of recruitment
- Brazil
Study participating centre
sala 719
Vitória
29050335
Brazil
Sponsor information
Other
Avenida Arriaga, 73
Escritório 105
Ilha da Madeira
9000-064
Portugal
| Phone | +351 938 259 609 |
|---|---|
| andre@vermiliongroup.org | |
| Website | https://www.micillic.pt |
Funders
Funder type
Industry
No information available
No information available
Results and Publications
| Intention to publish date | 20/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data collected from the volunteers will not be disclosed anonymously in order to preserve the identity and confidentiality defined in the research consent term, the collected data being identified by random numbers and stored on their own servers in an encrypted folder, in case of interest of Access to the data can be requested through the email adm@gon1.com.br or at https://gon1.com.br/ipd and it is mandatory to present a technical justification and complete identification of the requester. |
Editorial Notes
28/07/2025: Internal review.
22/08/2023: Trial's existence confirmed by Universidade Vila Velha - ES/UVV.
