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

Parkinson Disease Clinical Trial

Official title:

Clinical Study Evaluating the Efficacy and Safety of Synbiotic as an Adjuvant Therapy in the Treatment of Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05576818
• Other study ID #: Synbiotics Parkinson's disease
• Status: Recruiting
• Phase: Phase 3
• Start date: June 30, 2022
• Est. completion date: June 2025

Study information

• Verified date: October 2022
• Source: Tanta University
• Contact: Mohamed E Ramadan
• Phone: 201205280849
• Email: mohamed_ehab[@]pharm.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	El Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The change in the serum level of a-Synuclein	Blood samples will be collected at baseline and after 3 months	3 months
Secondary	The change in the serum level of Tumor necrosis factor a (TNF a )	Blood samples will be collected at baseline and after 3 months	3 months
Secondary	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
Secondary	The change in the serum level of Malondialdehyde (MDA)	Blood samples will be collected at baseline and after 3 months	3 months