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Gut Health and Probiotics in Parkinson's (SymPD)

Primary Purpose

Parkinson Disease

Status

Active

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Multi-strain probiotic

Placebo

About this trial

This is an interventional other trial for Parkinson Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

King's College Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

food supplement: multi-strain probiotic (Symprove)

Placebo

Arm Description

70 ml daily for 12 weeks

Outcomes

Primary Outcome Measures

Gut microbiota of study population

Gut microbiota will be evaluated with shallow shotgun sequencing of stool samples

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

Secondary Outcome Measures

Blood

Changes in blood levels of inflammatory markers (i.e. C-reactive protein, cytokines, tight junction proteins, and short-chain fatty acids levels)

Full Information

NCT ID

NCT05146921

First Posted

November 2, 2021

Last Updated

September 1, 2022

Sponsor

King's College Hospital NHS Trust

Collaborators

King's College London

1. Study Identification

Unique Protocol Identification Number

NCT05146921

Brief Title

Gut Health and Probiotics in Parkinson's (SymPD)

Official Title

Gut Health and Probiotics in Parkinson's (SymPD)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 4, 2019 (Actual)

Primary Completion Date

July 15, 2023 (Anticipated)

Study Completion Date

July 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

King's College Hospital NHS Trust

Collaborators

King's College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

food supplement: multi-strain probiotic (Symprove)

Arm Type

Active Comparator

Arm Description

70 ml daily for 12 weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

70 ml daily for 12 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

Multi-strain probiotic

Other Intervention Name(s)

Symprove

Intervention Description

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

Other

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Gut microbiota of study population

Description

Gut microbiota will be evaluated with shallow shotgun sequencing of stool samples

Time Frame

Baseline

Title

Changes of gut microbiota following probiotic intervention and their association with changes in Parkinson's symptoms

Description

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

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Blood

Description

Changes in blood levels of inflammatory markers (i.e. C-reactive protein, cytokines, tight junction proteins, and short-chain fatty acids levels)

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

K Ray Chaudhuri, Professor

Organizational Affiliation

King's College London

Official's Role

Principal Investigator

Facility Information:

Facility Name

King's College Hospital NHS Foundation Trust

City

London

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Gut Health and Probiotics in Parkinson's (SymPD)

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