Gut Health and Probiotics in Parkinson's (SymPD)

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 Overview

• Status: Active, not recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Dietary supplement: Multi-strain probiotic; Other: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE5 9RS
    • King's College Hospital NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: King's College Hospital NHS Trust
• Collaborators: King's College London

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2019
• Primary Completion (Anticipated): July 15, 2023
• Study Completion (Anticipated): July 15, 2023

Study Registration Dates

• First Submitted: November 2, 2021
• First Submitted That Met QC Criteria: November 23, 2021
• First Posted (Actual): December 7, 2021

Study Record Updates

• Last Update Posted (Actual): September 2, 2022
• Last Update Submitted That Met QC Criteria: September 1, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: KCH19-085

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No