Effect of Synbiotic as an Adjuvant Therapy in the Treatment of Parkinson's Disease

Phase 3

Recruiting

• Conditions: Parkinson Disease
• Interventions: Drug: Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibers

• Registration Number: NCT05576818
• Lead Sponsor: Tanta University

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-06-30
• Status Verified: 2022-10
• Study First Submitted: 2022-10-10
• Study First Submitted QC: 2022-10-10
• Last Update Submitted: 2022-10-10
• Study First Posted: 2022-10-13
• Last Update Posted: 2022-10-13
• Primary Completion: 2024-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 66

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Synbiotic group	Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibers	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El Gharbia, Egypt