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

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibers
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Tanta UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control group

Synbiotic group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The change in the serum level of α-Synuclein
Blood samples will be collected at baseline and after 3 months
The change in the serum level of Tumor necrosis factor α (TNF α )
Blood samples will be collected at baseline and after 3 months
The change in the serum level of Brain derived neurotrophic factor ( BDNF)
Blood samples will be collected at baseline and after 3 months
The change in the serum level of Malondialdehyde (MDA)
Blood samples will be collected at baseline and after 3 months

Full Information

First Posted
October 10, 2022
Last Updated
October 10, 2022
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT05576818
Brief Title
Effect of Synbiotic as an Adjuvant Therapy in the Treatment of Parkinson's Disease
Official Title
Clinical Study Evaluating the Efficacy and Safety of Synbiotic as an Adjuvant Therapy in the Treatment of Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
this group will include 33 patients who will receive their standard dopamine replacement therapy for 3 months
Arm Title
Synbiotic group
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibers
Other Intervention Name(s)
Synbiotic
Intervention Description
Two sachets daily of synbiotic preparation containing Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibers
Primary Outcome Measure Information:
Title
The change in MDS-Unified Parkinson's Disease Rating Scale.
Description
Patients will undergo clinical assessment according to MDS-Unified Parkinson's Disease Rating Scale at baseline and after 3 months
Time Frame
3 months
Secondary Outcome Measure Information:
Title
The change in the serum level of α-Synuclein
Description
Blood samples will be collected at baseline and after 3 months
Time Frame
3 months
Title
The change in the serum level of Tumor necrosis factor α (TNF α )
Description
Blood samples will be collected at baseline and after 3 months
Time Frame
3 months
Title
The change in the serum level of Brain derived neurotrophic factor ( BDNF)
Description
Blood samples will be collected at baseline and after 3 months
Time Frame
3 months
Title
The change in the serum level of Malondialdehyde (MDA)
Description
Blood samples will be collected at baseline and after 3 months
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed E Ramadan
Phone
201205280849
Email
mohamed_ehab@pharm.tanta.edu.eg
Facility Information:
Facility Name
Tanta University
City
Tanta
State/Province
El Gharbia
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed E Ramadan
Phone
201205280849
Email
mohamed_ehab@pharm.tanta.edu.eg

12. IPD Sharing Statement

Learn more about this trial

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

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