Parkinson's DiseasePhase 3NCT05576818
Effect of Synbiotic as an Adjuvant Therapy in the Treatment of Parkinson's Disease
A Phase 3 study testing Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibers in people with Parkinson's Disease, run by Tanta University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2022to Jun 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El Gharbia
Mohamed E Ramadan, 201205280849, mohamed_ehab@pharm.tanta.edu.eg
About this study
Official title: Clinical Study Evaluating the Efficacy and Safety 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
- Conditions
- Parkinson's Disease
- Being tested
- Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibers
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibersDrug
Also called Synbiotic
Two sachets daily of synbiotic preparation containing Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibers
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (4)
The change in the serum level of α-Synuclein
Blood samples will be collected at baseline and after 3 months
Measured: 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
Measured: 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
Measured: 3 months
The change in the serum level of Malondialdehyde (MDA)
Blood samples will be collected at baseline and after 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start30 Jun 2022
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ehab Sayed Ramadan, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05576818
- Sponsor's protocol ID
- Synbiotics Parkinson's disease
- Status last verified
- Apr 2025
- First submitted
- 10 Oct 2022
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 40434674
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Efficacy and Safety of Synbiotic as an Adjuvant Therapy in the Treatment of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05576818
- Acronym / sponsor ID
- Synbiotics Parkinson's disease
- Conditions
- Parkinson's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibersthis 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 |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibersAlso: SynbioticTwo sachets daily of synbiotic preparation containing Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibers | Drug | Synbiotic group |
Primary outcome
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Derived from this study: PubMed 40434674Ramadan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lactobacillus acidophilus 10 billion colony forming unit (CFU) and prebiotic fibers in people with Parkinson's Disease, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed E Ramadan (201205280849, mohamed_ehab@pharm.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in MDS-Unified Parkinson's Disease Rating Scale. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05576818, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.