Lactobacillus acidophilus 10 billi… for Parkinson's (NCT05576818)
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
Summary For Families
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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 3 trial is estimated to last approximately 2 years and 11 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This trial has a group that receives no study treatment (you would continue your usual care) alongside the treatment group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the no-treatment group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.