Observational, Cross-sectional Clinical Study in Parkinson's Disease (PD) Patients and Healthy Controls (HC) to Identify PD Specific Microbial and Metabolic Fingerprints in Small Intestinal (SI) Fluid and Blood
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Nimble Science Ltd.
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Difference in microbiome profile of small intestine samples between groups
Study Overview
Brief Summary
Observational cross-sectional study in PD patients and healthy controls (HC) using an investigational medical device consisting of a passive small intestine microbiome aspiration (SIMBA) system (capsule) that is ingested orally and recovered together with the stools (home recovery) together with blood sampling (during the onsite visit).
Detailed Description
Participants will be swallowing two SIMBA capsules which allows for minimally-invasive sampling of the microbiome and metabolome deep in the small intestine. Researchers will use the capsule samples to determine the small intestinal microbiome and metabolomic signatures in luminal fluid samples from the small bowel in Parkinson Disease (PD) patients compared to healthy controls (HC).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 50 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Healthy control (HC)
25 neurotypical controls, age-matched to the Parkinson's disease group
Intervention: Fluid biopsy capsule (Device)
Parkinson's disease (PD)
75 Parkinson's disease patients
Intervention: Fluid biopsy capsule (Device)
Parkinson's disease (PD)
75 Parkinson's disease patients
Intervention: Levodopa-Carbidopa Immediate Release (Drug)
Outcomes
Primary Outcomes
Difference in microbiome profile of small intestine samples between groups
Time Frame: Baseline
Functional dysbiosis profile of the small intestinal microbiota of Parkinson's Disease patients compared to age-matched neurotypical controls, as determined by whole metagenome shotgun sequencing based profiling
Secondary Outcomes
- Difference in blood metabolome composition between groups(Baseline)
- Correlation between the observed small intestine microbiome profile and blood metabolome composition, including, in PD subjects, levodopa pharmacodynamics(Baseline)