Probiotic supplementation with Lactiplantibacillus plantarum OL3246 and quality of life of patients with Parkinson's disease
| ISRCTN | ISRCTN22987788 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22987788 |
| Sponsor | Olimp Laboratories Sp. z o.o. |
| Funder | Narodowe Centrum Badań i Rozwoju |
- Submission date
- 22/06/2026
- Registration date
- 14/08/2026
- Last edited
- 14/08/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Andrzej Małecki
Principal investigator, Scientific, Public
Principal investigator, Scientific, Public
Laboratory of Molecular Biology, Institute of Physiotherapy and Health Sciences, Academy of Physical Education, Mikołowska 72a
Katowice
40-065
Poland
| Phone | +48322075435 |
|---|---|
| a.malecki@awf.katowice.pl |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Placebo |
| Assignment | Parallel |
| Purpose | Basic science, Treatment |
| Scientific title | A randomized, double-blind, placebo-controlled pilot trial evaluating the effect of Lactiplantibacillus plantarum OL3246 on quality of life, depressive sympthoms, neurodegenerative and gut–redox biomarkers in patients with Parkinson's disease |
| Study objectives | |
| Ethics approval(s) |
Approved 23/06/2022, University Bioethics Committee for Scientific Research at the Jerzy Kukuczka Academy of Physical Education in Katowice (Mikołowska 72A, Katowice, 40-065, Poland; +48322075433; komisjabioetyczna@awf.katowice.pl), ref: Resolution No. 6/2022 |
| Health condition(s) or problem(s) studied | Evaluating supplementation effect on quality of life in patients with Parkinson's disease. |
| Intervention | Permuted-block randomization with a fixed block size of four (2:2 ratio) was generated using a computer algorithm. Both participants and researchers were blinded to the group allocation. 1. Intervention group: capsules, containing Lactiplantibacillus plantarum OL3246 (deposit number: KPD 1760) lyophilizate and excipients (1.4 × 10^10 CFU per day; taken orally as a 370 mg capsule containing 7 × 10^9 CFU/capsule twice a day: morning and evening). 2. Placebo group: Placebo capsules contained an equal mass of fulfillment, while the probiotic was substituted by maltodextrin (taken orally as a 370 mg capsule twice a day: morning and evening). The duration of the intervention is 3 months. |
| Intervention type | Supplement |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 15/11/2023 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 55 Years |
| Upper age limit | 85 Years |
| Sex | All |
| Target sample size at registration | 36 |
| Total final enrolment | 36 |
| Key inclusion criteria | 1. Diagnosed Parkinson's disease according to UK PDS BB 2. Overall good health condition 3. MMSE > 24 |
| Key exclusion criteria | 1. Diagnosed dementia 2. Diabetes mellitus 3. Clinically active depression (BDI > 26 and positive clinical diagnosis) 4. Substance use disorders or intoxication 5. Uncontrolled hypertension 6. Unstable ischemic heart disease 7. Allergies, particularly severe allergic reactions 8. Other serious medical conditions that, in the investigator’s opinion, could interfere with test performance or supplement tolerance 9. Use of psychotropic medications 10. Use of antibiotics and probiotics during past 3 months 11. Major changes in diet in last 3 months |
| Date of first enrolment | 01/06/2023 |
| Date of final enrolment | 15/07/2023 |
Locations
Countries of recruitment
- Poland
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
22/06/2026: Study’s existence confirmed by the University Bioethics Committee for Scientific Research at the Jerzy Kukuczka Academy of Physical Education in Katowice, Poland.
