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Gut Health and Probiotics in Parkinson's (SymPD)

Sponsor
King's College Hospital NHS Trust (Other)
Overall Status
Recruiting
CT.gov ID
NCT05146921
Collaborator
King's College London (Other)
60
Enrollment
1
Location
2
Arms
48.4
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Multi-strain probiotic
  • Other: Placebo
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Gut Health and Probiotics in Parkinson's (SymPD)
Actual Study Start Date :
Jul 4, 2019
Anticipated Primary Completion Date :
Jul 15, 2023
Anticipated Study Completion Date :
Jul 15, 2023

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Gut microbiota of study population [Baseline]

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

    2. Changes of gut microbiota following probiotic intervention and their association with changes in Parkinson's symptoms [12 weeks]

      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

    1. Blood [12 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 King's College Hospital NHS Foundation Trust London United Kingdom SE5 9RS

    Sponsors and Collaborators

    • King's College Hospital NHS Trust
    • King's College London

    Investigators

    • Principal Investigator: K Ray Chaudhuri, Professor, King's College London

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    King's College Hospital NHS Trust
    ClinicalTrials.gov Identifier:
    NCT05146921
    Other Study ID Numbers:
    • KCH19-085
    First Posted:
    Dec 7, 2021
    Last Update Posted:
    Dec 7, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Parkinson Disease

    Study Results

    No Results Posted as of Dec 7, 2021