Gut Health and Probiotics in Parkinson's (SymPD)

NCT05146921 | Unknown

• 1 other identifier: KCH19-085
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Blood

  12 weeks

Study Arms (2)

food supplement: multi-strain probiotic (Symprove)

ACTIVE COMPARATOR

70 ml daily for 12 weeks

Dietary Supplement: Multi-strain probiotic

Placebo

PLACEBO COMPARATOR

70 ml daily for 12 weeks

Other: Placebo

Interventions

Multi-strain probiotic 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

Also known as: Symprove

food supplement: multi-strain probiotic (Symprove)

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead
• King's College London: collaborator

Study Sites (1)

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• K Ray Chaudhuri, Professor

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: December 7, 2021
• Study Start: July 4, 2019
• Primary Completion: July 15, 2023
• Study Completion: July 15, 2023
• Last Updated: September 2, 2022

Record last verified: 2022-09

Locations

GB (1)