Effect of Synbiotic as an Adjuvant Therapy in the Treatment of 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 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

Study Overview

• Status: Recruiting
• Conditions: Parkinson's Disease
• Intervention / Treatment: Drug: Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibers

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Mohamed E Ramadan; Phone Number: 201205280849; Email: mohamed_ehab@pharm.tanta.edu.eg

Study Locations

• Egypt
  • El Gharbia
    • Tanta, El Gharbia, Egypt
      • Recruiting
      • Tanta University
      • Contact: Mohamed E Ramadan; Phone Number: 201205280849; Email: mohamed_ehab@pharm.tanta.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; this group will include 33 patients who will receive their standard dopamine replacement therapy for 3 months
Active Comparator: Synbiotic group; this group will involve 33 patients who will receive Synbiotic preparation containing Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibers 2 sachets daily together with their standard dopamine replacement therapy for 3 months	Drug: Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibers; Two sachets daily of synbiotic preparation containing Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibers; Other Names: Synbiotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in MDS-Unified Parkinson's Disease Rating Scale.	Patients will undergo clinical assessment according to MDS-Unified Parkinson's Disease Rating Scale at baseline and after 3 months	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in the serum level of α-Synuclein	Blood samples will be collected at baseline and after 3 months	3 months
The change in the serum level of Tumor necrosis factor α (TNF α )	Blood samples will be collected at baseline and after 3 months	3 months
The change in the serum level of Brain derived neurotrophic factor ( BDNF)	Blood samples will be collected at baseline and after 3 months	3 months
The change in the serum level of Malondialdehyde (MDA)	Blood samples will be collected at baseline and after 3 months	3 months

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2022
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: October 10, 2022
• First Submitted That Met QC Criteria: October 10, 2022
• First Posted (Actual): October 13, 2022

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: Synbiotics Parkinson's disease

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No