Reduce motor symptoms using synbiotic
- Trial ID
- NCT05576818
- Official Title
- Clinical Study Evaluating the Efficacy and Safety of Synbiotic as an Adjuvant Therapy in the Treatment of Parkinson's Disease
- Goal
- Reduce motor symptoms using synbiotic
- Phase
- PHASE3
- Status
- RECRUITING
- Sponsor
- Tanta University
- Study Type
- INTERVENTIONAL
- Enrollment
- 66 participants
- Conditions
- Parkinson's Disease
- Interventions
- Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibers
Plain-Language Summary
The goal is to test whether adding a specific synbiotic can safely boost the effect of dopamine replacement and improve Parkinson's symptoms and related gut inflammation. The approach gives Lactobacillus acidophilus 10 billion CFU plus prebiotic fibers, the probiotic supplies beneficial bacteria and the prebiotic feeds them, with the idea of rebalancing the gut microbiome, reducing gut inflammation and oxidative stress, and possibly improving levodopa absorption or response. Eligible participants are adults 45 to 65 with Parkinson's on dopamine replacement and Hoehn and Yahr stages 1 to 4; people recently on antibiotics or other probiotics, with recent or planned GI surgery, probiotic allergy, enteral/IV nutrition, depression or psychosis, active inflammatory or oxidative-stress conditions, hyperthyroidism, smokers, or those taking antioxidant/anti-inflammatory drugs are excluded.
Locations
- Tanta University, Tanta, El Gharbia, Egypt
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibers. The goal is to test whether adding a specific synbiotic can safely boost the effect of dopamine replacement and improve Parkinson's symptoms and related gut inflammation. The approach gives Lactobacillus acidophilus 10 billion CFU plus prebiotic fibers, the probiotic supplies beneficial bacteria and the prebiotic feeds them, with the idea of rebalancing the gut microbiome, reducing gut inflammation and oxidative stress, and possibly improving levodopa absorption or response. Eligible participants are adults 45 to 65 with Parkinson's on dopamine replacement and Hoehn and Yahr stages 1 to 4; people recently on antibiotics or other probiotics, with recent or planned GI surgery, probiotic allergy, enteral/IV nutrition, depression or psychosis, active inflammatory or oxidative-stress conditions, hyperthyroidism, smokers, or those taking antioxidant/anti-inflammatory drugs are excluded.
- Who can participate?
- Participants must be between 45 Years and 65 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 3 trial is estimated to last approximately 2 years and 11 months.