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NCT Number: NCT05576818

Effect 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

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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

Other names: Synbiotic

Primary outcomes

  1. The change in MDS-Unified Parkinson's Disease Rating Scale.

    Time frame: 3 months

    Patients will undergo clinical assessment according to MDS-Unified Parkinson's Disease Rating Scale at baseline and after 3 months

Secondary outcomes

  1. The change in the serum level of α-Synuclein

    Time frame: 3 months

    Blood samples will be collected at baseline and after 3 months

  2. The change in the serum level of Tumor necrosis factor α (TNF α )

    Time frame: 3 months

    Blood samples will be collected at baseline and after 3 months

  3. The change in the serum level of Brain derived neurotrophic factor ( BDNF)

    Time frame: 3 months

    Blood samples will be collected at baseline and after 3 months

  4. The change in the serum level of Malondialdehyde (MDA)

    Time frame: 3 months

    Blood samples will be collected at baseline and after 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed E Ramadan

CONTACT

[email protected]

201205280849

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 13, 2022
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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