NCT05576818 Effect of Synbiotic as an Adjuvant Therapy in the Treatment of Parkinson's Disease
| NCT ID | NCT05576818 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Tanta University |
| Condition | Parkinson's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2022-06-30 |
| Primary Completion | 2025-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 66 participants in total. It began in 2022-06-30 with a primary completion date of 2025-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05576818 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 65 Years, studying Parkinson's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05576818 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 66 participants.
Is NCT05576818 currently recruiting?
Yes, NCT05576818 is actively recruiting participants. Contact the research team at mohamed_ehab@pharm.tanta.edu.eg for enrollment information.
Where is the NCT05576818 trial being conducted?
This trial is being conducted at Tanta, Egypt.
Who is sponsoring the NCT05576818 clinical trial?
NCT05576818 is sponsored by Tanta University. The trial plans to enroll 66 participants.
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