Gut Health and Probiotics in Parkinson's (SymPD)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-04

Study Completion Date

2023-07-15

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.

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Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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food supplement: multi-strain probiotic (Symprove)

70 ml daily for 12 weeks

Group Type ACTIVE_COMPARATOR

Multi-strain probiotic

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

70 ml daily for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

placebo similar in appearance and taste to the active intervention but with no active bacteria

Interventions

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Multi-strain probiotic

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

placebo similar in appearance and taste to the active intervention but with no active bacteria

Intervention Type OTHER

Other Intervention Names

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Symprove

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No