Parkinson DiseaseNCT05146921
Gut Health and Probiotics in Parkinson's (SymPD)
A study testing Multi-strain probiotic in people with Parkinson Disease, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
Current literature suggests that the gut microbiota is altered in patients with Parkinson's disease (PD) and might play a role in the clinical presentation and pathogenesis of this condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Multi-strain probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jul 2019to 15 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18 and upwards
- Diagnosis of idiopathic Parkinson's disease according to the Movement Disorder Society clinical diagnostic criteria
- Hoehn Yarh stage II-IV
- Diagnosis of constipation according to the ROME IV criteria and ≤ than 3 complete bowel movements per week
Who cannot join
- Diagnosis or suspicion of other causes for parkinsonism
- Advanced-stage therapies (deep brain stimulation, intrajejunal levodopa infusion, and apomorphine subcutaneous infusion)
- Any inflammatory bowel disease or diseases of the colon
- Previous surgery on the gastrointestinal tract
- History of laxative abuse
- Ongoing artificial nutrition
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- Regular use of probiotics
- Previous intolerance and/or adverse reactions to probiotics
- Previous use of Symprove
- Recent or current use of any antibiotics (within 4 weeks before the start of the study)
- Swallowing issues interfering with the safety intake of the probiotic/placebo
- Pregnancy or lactation
- Major systemic disease
- Any condition interfering with the ability to give the informed consent
- Enrolment in another simultaneous investigational trial
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
King's College Hospital NHS Foundation Trust
London, SE5 9RS
About this study
Current literature suggests that the gut microbiota is altered in patients with Parkinson's disease (PD) and might play a role in the clinical presentation and pathogenesis of this condition. The latter has driven the interest in investigating the use of gut microbiota-modulating interventions, such as probiotics, as possible novel therapeutic strategies for PD. Symprove is a food supplement working as an oral active probiotic which unlike many commercially available probiotics can reach the intestine and has been shown to be beneficial for gut health in gastrointestinal disorders.To date, no research has explored the possible effects of the intake of Symprove in PD. This is an exploratory study with a randomised, double-blind, placebo-controlled design investigating the effects of a 12-week probiotic intervention (Symprove) on gut and general health in 60 patients with PD and constipation.
- Conditions
- Parkinson Disease
- Being tested
- Multi-strain probiotic, Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-strain probioticDietary supplement
Also called Symprove
The intervention in this study is a multi-strain probiotic which contains four live strains of bacteria:
Lacticaseibacillus rhamnosus NCIMB 30174 Enterococcus faecium NCIMB 30176 Lactobacillus acidophilus NCIMB 30175 Lactiplantibacillus plantarum NCIMB 30173
10 billion colony-forming units (CFU) per 70 ml cup
PlaceboOther
placebo similar in appearance and taste to the active intervention but with no active bacteria
| Study group | Role | What they receive |
|---|---|---|
| food supplement: multi-strain probiotic (Symprove) | Active comparator | 70 ml daily for 12 weeks Receives: Dietary Supplement: Multi-strain probiotic |
| Placebo | Placebo comparator | 70 ml daily for 12 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiota of study population
Gut microbiota will be evaluated with shallow shotgun sequencing of stool samples
Measured: Baseline
Changes of gut microbiota following probiotic intervention and their association with changes in Parkinson's symptoms
Gut microbiota changes will be evaluated with shallow shotgun sequencing of stool samples while Parkinson's symptoms changes will be evaluated with subjective and objective measurements
Measured: 12 weeks
Secondary outcomes (1)
Blood
Changes in blood levels of inflammatory markers (i.e. C-reactive protein, cytokines, tight junction proteins, and short-chain fatty acids levels)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start4 Jul 2019
- Primary completion15 Jul 2023 (estimated)
- Study completion15 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- K Ray Chaudhuri, Professor, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146921
- Sponsor's protocol ID
- KCH19-085
- Status last verified
- Sep 2022
- First submitted
- 2 Nov 2021
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Health and Probiotics in Parkinson's (SymPD)
- ClinicalTrials.gov ID
- NCT05146921
- Acronym / sponsor ID
- KCH19-085
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 4 Jul 2019 (actual)
- Primary completion
- 15 Jul 2023 (estimated)
- Study completion
- 15 Jul 2023 (estimated)
- First posted
- 7 Dec 2021 (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.
Current literature suggests that the gut microbiota is altered in patients with Parkinson's disease (PD) and might play a role in the clinical presentation and pathogenesis of this condition. The latter has driven the interest in investigating the use of gut microbiota-modulating interventions, such as probiotics, as possible novel therapeutic strategies for PD. Symprove is a food supplement working as an oral active probiotic which unlike many commercially available probiotics can reach the intestine and has been shown to be beneficial for gut health in gastrointestinal disorders.To date, no research has explored the possible effects of the intake of Symprove in PD. This is an exploratory study with a randomised, double-blind, placebo-controlled design investigating the effects of a 12-week probiotic intervention (Symprove) on gut and general health in 60 patients with PD and constipation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| food supplement: multi-strain probiotic (Symprove) | Active comparator | Dietary Supplement: Multi-strain probiotic70 ml daily for 12 weeks |
| Placebo | Placebo comparator | Other: Placebo70 ml daily for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age of 18 and upwards
- Diagnosis of idiopathic Parkinson's disease according to the Movement Disorder Society clinical diagnostic criteria
- Hoehn Yarh stage II-IV
- Diagnosis of constipation according to the ROME IV criteria and ≤ than 3 complete bowel movements per week
Key exclusion criteria (15 listed)
- Diagnosis or suspicion of other causes for parkinsonism
- Advanced-stage therapies (deep brain stimulation, intrajejunal levodopa infusion, and apomorphine subcutaneous infusion)
- Any inflammatory bowel disease or diseases of the colon
- Previous surgery on the gastrointestinal tract
- History of laxative abuse
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 |
|---|---|---|
| Multi-strain probioticAlso: SymproveThe intervention in this study is a multi-strain probiotic which contains four live strains of bacteria: Lacticaseibacillus rhamnosus NCIMB 30174 Enterococcus faecium NCIMB 30176 Lactobacillus acidophilus NCIMB 30175 Lactiplantibacillus plantarum NCIMB 30173 10 billion colony-forming units (CFU) per 70 ml cup | Dietary supplement | food supplement: multi-strain probiotic (Symprove) |
| Placeboplacebo similar in appearance and taste to the active intervention but with no active bacteria | Other | Placebo |
Primary outcome
Gut microbiota of study population
Time frame: Baseline
Gut microbiota will be evaluated with shallow shotgun sequencing of stool samples
Changes of gut microbiota following probiotic intervention and their association with changes in Parkinson's symptoms
Time frame: 12 weeks
Gut microbiota changes will be evaluated with shallow shotgun sequencing of stool samples while Parkinson's symptoms changes will be evaluated with subjective and objective measurements
1 secondary outcome
Blood
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
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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. This study is not recruiting at the moment.
K Ray Chaudhuri, Professor principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-strain probiotic in people with Parkinson Disease, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
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 15 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: status not confirmed, as of the sponsor's last update on 2 Sep 2022. 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 United Kingdom. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiota of study population (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2022.