A Phase 3 interventional study of Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibers in Parkinson's Disease, sponsored by Tanta University. Recruiting at 1 site in Egypt. Open to participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-04-10.
Sponsored by Tanta University · Phase 3, Interventional, and Treatment
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
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's planned enrollment of 66 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
this group will include 33 patients who will receive their standard dopamine replacement therapy for 3 months
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
Two sachets daily of synbiotic preparation containing Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibers
Also known as: Synbiotic
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
Time frame: 3 months
The change in the serum level of α-Synuclein
Blood samples will be collected at baseline and after 3 months
Time frame: 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
Time frame: 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
Time frame: 3 months
The change in the serum level of Malondialdehyde (MDA)
Blood samples will be collected at baseline and after 3 months
Time frame: 3 months
Plan to share: No
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