NCT05576818

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2022

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 13, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

April 10, 2025

Status Verified

April 1, 2025

Enrollment Period

2.9 years

First QC Date

October 10, 2022

Last Update Submit

April 7, 2025

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • 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

    3 months

Secondary Outcomes (4)

  • The change in the serum level of α-Synuclein

    3 months

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

    3 months

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

    3 months

  • The change in the serum level of Malondialdehyde (MDA)

    3 months

Study Arms (2)

Control group

NO INTERVENTION

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

Synbiotic group

ACTIVE COMPARATOR

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

Interventions

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

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

Also known as: Synbiotic
Synbiotic group

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, El Gharbia, Egypt

RECRUITING

Related Publications (1)

  • Ramadan ME, Mostafa TM, Ghali AA, El-Afify DR. Randomized controlled trial evaluating synbiotic supplementation as an adjuvant therapy in the treatment of Parkinson's disease. Inflammopharmacology. 2025 Jul;33(7):3897-3908. doi: 10.1007/s10787-025-01752-8. Epub 2025 May 28.

    PMID: 40434674DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Synbiotics

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

PrebioticsDietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaProbioticsFood and Beverages

Central Study Contacts

Mohamed E Ramadan

CONTACT

201205280849mohamed_ehab@pharm.tanta.edu.eg

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator at clinical pharmacy department, faculty of pharmacy

Study Record Dates

First Submitted

October 10, 2022

First Posted

October 13, 2022

Study Start

June 30, 2022

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

April 10, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)