Gut Health and Probiotics in Parkinson's (SymPD)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 September 2022
• Main ID: NCT05146921
• Date of registration: 02/11/2021
• Prospective Registration: No
• Primary sponsor: King's College Hospital NHS Trust
• Public title: Gut Health and Probiotics in Parkinson's (SymPD)
• Scientific title: Gut Health and Probiotics in Parkinson's (SymPD)
• Date of first enrolment: July 4, 2019
• Target sample size: 60
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT05146921
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

United Kingdom

Contacts

• Name: K Ray Chaudhuri, Professor
• Affiliation: King's College London

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Dietary Supplement: Multi-strain probiotic

Other: Placebo

Primary Outcome(s)

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

Gut microbiota of study population [Time Frame: Baseline]

Secondary Outcome(s)

Blood [Time Frame: 12 weeks]

Secondary ID(s)

KCH19-085

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

King's College London