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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | this group will include 33 patients who will receive their standard dopamine replacement therapy for 3 months | |
| Synbiotic group | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibers | Drug | Two sachets daily of synbiotic preparation containing Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibers |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed E Ramadan | Contact | 201205280849 | mohamed_ehab@pharm.tanta.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University | Recruiting | Tanta | El Gharbia | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40434674 | Derived | Ramadan ME, Mostafa TM, Ghali AA, El-Afify DR. Randomized controlled trial evaluating synbiotic supplementation as an adjuvant therapy in the treatment of Parkinson's disease. Inflammopharmacology. 2025 Jul;33(7):3897-3908. doi: 10.1007/s10787-025-01752-8. Epub 2025 May 28. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D058616 | Synbiotics |
| ID | Term |
|---|---|
| D056692 | Prebiotics |
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
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|
| 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 |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D010829 |
| Physiological Phenomena |
| D019936 | Probiotics |
| D019602 | Food and Beverages |