Recruiting NCT05576818
Effect of Synbiotic as an Adjuvant Therapy in the Treatment of Parkinson's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibers.
- Who it may be relevant to
- Registry conditions: Parkinson's Disease. Basic parameters: 45 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Study Evaluating the Efficacy and Safety of Synbiotic as an Adjuvant Therapy in the Treatment of Parkinson's Disease
Overview
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
Interventions
- 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
Primary outcome measures
- The change in MDS-Unified Parkinson's Disease Rating Scale. [Time frame: 3 months]
Secondary outcome measures (4)
- The change in the serum level of α-Synuclein [Time frame: 3 months]
- The change in the serum level of Tumor necrosis factor α (TNF α ) [Time frame: 3 months]
- The change in the serum level of Brain derived neurotrophic factor ( BDNF) [Time frame: 3 months]
- The change in the serum level of Malondialdehyde (MDA) [Time frame: 3 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Tanta University — Tanta
Publications
- 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 40434674
Identifiers
NCT: NCT05576818 · Synbiotics Parkinson's disease