Gut Health and Probiotics in Parkinson's (SymPD)

Parkinson Disease Clinical Trial

Official title:

Gut Health and Probiotics in Parkinson's (SymPD)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05146921
• Other study ID #: KCH19-085
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 4, 2019
• Est. completion date: July 15, 2023

Study information

• Verified date: September 2022
• Source: King's College Hospital NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: July 15, 2023
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
United Kingdom	King's College Hospital NHS Foundation Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College Hospital NHS Trust	King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gut microbiota of study population	Gut microbiota will be evaluated with shallow shotgun sequencing of stool samples	Baseline
Primary	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	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