Using synbiotics to help treat Parkinson's disease
Clinical Study Evaluating the Efficacy and Safety of Synbiotic as an Adjuvant Therapy in the Treatment of Parkinson's Disease
This study is testing if a special mix of good bacteria and fibers can help improve treatment for people with Parkinson's disease who are already on medication.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 45 Years to 65 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, El Gharbia) |
| Trial ID | NCT05576818 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy and safety of a synbiotic preparation combining Lactobacillus acidophilus and prebiotic fibers as an additional treatment for patients with Parkinson's disease. Participants aged 45 to 65 who are currently on dopamine replacement therapy will be enrolled. The study aims to assess whether this synbiotic approach can enhance treatment outcomes for individuals with varying stages of Parkinson's disease. The intervention involves administering 10 billion CFU of Lactobacillus acidophilus along with prebiotic fibers.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 45 to 65 with Parkinson's disease who are currently receiving dopamine replacement therapy.
Not a fit: Patients with advanced Parkinson's disease (stage 5) or those with certain comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve the management of Parkinson's disease symptoms and overall patient quality of life.
How similar studies have performed: While the use of probiotics in neurological conditions is an emerging field, this specific approach has not been widely tested, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 45 and 65 years old * Both sexes * Patients with Parkinson's disease on dopamine replacement therapy * Modified Hoehn and Yahr stage, MHY 1-4 Exclusion Criteria: * Patients who are currently using or used antibiotics therapy in the preceding month * Patients who are currently using or used other probiotic products in the preceding two weeks * Patients scheduled to undergo GIT surgery or those underwent GIT surgery * Patients with Known allergy to probiotics * Patients receiving artificial enteral or intravenous nutrition * Patients with depression and/or psychosis * Patients taking antioxidant and/or anti-inflammatory medications * Patients with Hyperthyroidism * Patients with inflammatory condition and/or condition involving oxidative stress * Smokers * Modified Hoehn \& Yahr stage MHY 5
Where this trial is running
Tanta, El Gharbia
- Tanta University — Tanta, El Gharbia, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohamed E Ramadan
- Email: mohamed_ehab@pharm.tanta.edu.eg
- Phone: 201205280849
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.