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?
- 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.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.