Effect of Synbiotic as an Adjuvant Therapy in the Treatment of Parkinson's Disease

Study Overview
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Brief Summary
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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

Official Title
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Clinical Study Evaluating the Efficacy and Safety of Synbiotic as an Adjuvant Therapy in the Treatment of Parkinson's Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Drug: Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibers


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>this group will include 33 patients who will receive their standard dopamine replacement therapy for 3 months | |
| Active Comparator: Synbiotic group<br>this group will involve 33 patients who will receive Synbiotic preparation containing Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibers 2 sachets daily together with their standard dopamine replacement therapy for 3 months | Drug: Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibers<br>* Two sachets daily of synbiotic preparation containing Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibers<br>* Other names: Synbiotic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in MDS-Unified Parkinson's Disease Rating Scale. | Patients will undergo clinical assessment according to MDS-Unified Parkinson's Disease Rating Scale at baseline and after 3 months | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in the serum level of α-Synuclein | Blood samples will be collected at baseline and after 3 months | 3 months | 
| The change in the serum level of Tumor necrosis factor α (TNF α ) | Blood samples will be collected at baseline and after 3 months | 3 months | 
| The change in the serum level of Brain derived neurotrophic factor ( BDNF) | Blood samples will be collected at baseline and after 3 months | 3 months | 
| The change in the serum level of Malondialdehyde (MDA) | Blood samples will be collected at baseline and after 3 months | 3 months |