Parkinson's Disease
Conditions
Brief summary
This study aims to investigate the possible efficacy and safety of synbiotic preparation of Lactobacillus acidophilus probiotic with prebiotic fibers as an adjuvant therapy in the treatment of Parkinson's disease
Interventions
DRUGLactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibers
Two sachets daily of synbiotic preparation containing Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibers
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age between 45 and 65 years old * Both sexes * Patients with Parkinson's disease on dopamine replacement therapy * Modified Hoehn and Yahr stage, MHY 1-4
Exclusion criteria
* Patients who are currently using or used antibiotics therapy in the preceding month * Patients who are currently using or used other probiotic products in the preceding two weeks * Patients scheduled to undergo GIT surgery or those underwent GIT surgery * Patients with Known allergy to probiotics * Patients receiving artificial enteral or intravenous nutrition * Patients with depression and/or psychosis * Patients taking antioxidant and/or anti-inflammatory medications * Patients with Hyperthyroidism * Patients with inflammatory condition and/or condition involving oxidative stress * Smokers * Modified Hoehn & Yahr stage MHY 5
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in MDS-Unified Parkinson's Disease Rating Scale. | 3 months | Patients will undergo clinical assessment according to MDS-Unified Parkinson's Disease Rating Scale at baseline and after 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change in the serum level of α-Synuclein | 3 months | Blood samples will be collected at baseline and after 3 months |
| The change in the serum level of Tumor necrosis factor α (TNF α ) | 3 months | Blood samples will be collected at baseline and after 3 months |
| The change in the serum level of Brain derived neurotrophic factor ( BDNF) | 3 months | Blood samples will be collected at baseline and after 3 months |
| The change in the serum level of Malondialdehyde (MDA) | 3 months | Blood samples will be collected at baseline and after 3 months |
Countries
Egypt
Contacts
Primary ContactMohamed E Ramadan
Outcome results
None listed