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

Tanta University

Status and phase: Enrolling; Phase 3

Conditions: Parkinson's Disease

Treatments: Drug: Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibers

Study type: Interventional

Funder types: Other

Identifiers

NCT05576818

Synbiotics Parkinson's disease

Details and patient eligibility

About

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

Enrollment: 66 estimated patients

Sex: All

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Control group

No Intervention group

Description:

this group will include 33 patients who will receive their standard dopamine replacement therapy for 3 months

Synbiotic group

Active Comparator group

Description:

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

Treatment:

Drug: Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibers