Gut Health and Probiotics in Parkinson's (SymPD)

Study Overview
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Brief Summary
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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.

Official Title
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Gut Health and Probiotics in Parkinson's (SymPD)

Conditions
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Parkinson Disease

Intervention / Treatment
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* Dietary Supplement: Multi-strain probiotic
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: food supplement: multi-strain probiotic (Symprove)<br>70 ml daily for 12 weeks | Dietary Supplement: Multi-strain probiotic<br>* 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<br>* Other names: Symprove;|
| Placebo Comparator: Placebo<br>70 ml daily for 12 weeks | Other: Placebo<br>* placebo similar in appearance and taste to the active intervention but with no active bacteria<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut microbiota of study population | Gut microbiota will be evaluated with shallow shotgun sequencing of stool samples | 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 | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood | Changes in blood levels of inflammatory markers (i.e. C-reactive protein, cytokines, tight junction proteins, and short-chain fatty acids levels) | 12 weeks |