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

Sponsor
Tanta University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05576818
Collaborator
(none)
66
Enrollment
1
Location
2
Arms
35.1
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibers
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Study Evaluating the Efficacy and Safety of Synbiotic as an Adjuvant Therapy in the Treatment of Parkinson's Disease
Actual Study Start Date :
Jun 30, 2022
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control group

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

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
Other Names:
  • Synbiotic

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. The change in the serum level of α-Synuclein [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 ) [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) [3 months]

      Blood samples will be collected at baseline and after 3 months

    4. The change in the serum level of Malondialdehyde (MDA) [3 months]

      Blood samples will be collected at baseline and after 3 months

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tanta University Tanta El Gharbia Egypt

    Sponsors and Collaborators

    • Tanta University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mohamed Ehab Sayed Ramadan, Demonstrator at clinical pharmacy department, faculty of pharmacy, Tanta University
    ClinicalTrials.gov Identifier:
    NCT05576818
    Other Study ID Numbers:
    • Synbiotics Parkinson's disease
    First Posted:
    Oct 13, 2022
    Last Update Posted:
    Oct 13, 2022
    Last Verified:
    Oct 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Parkinson Disease

    Study Results

    No Results Posted as of Oct 13, 2022