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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-30

Study Completion Date

2025-06-30

Brief Summary

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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

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Detailed Description

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Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

Two sachets daily of synbiotic preparation containing Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibers

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Synbiotic

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No