Observational Small Intestine and Blood Fingerprint (SmIle) Study in Parkinson's Disease

Active, not recruiting

• Conditions: Parkinson Disease
• Interventions: Device: Fluid biopsy capsule; Drug: Levodopa-Carbidopa Immediate Release

• Registration Number: NCT06003608
• Lead Sponsor: Nimble Science Ltd.

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 Timeline

• Study First Submitted: 2023-08-02
• Study First Submitted QC: 2023-08-15
• Study First Posted: 2023-08-22
• Study Start: 2024-02-19
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-01-31
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Parkinson's disease (PD)	Levodopa-Carbidopa Immediate Release	75 Parkinson's disease patients
Parkinson's disease (PD)	Fluid biopsy capsule	75 Parkinson's disease patients
Healthy control (HC)	Fluid biopsy capsule	25 neurotypical controls, age-matched to the Parkinson's disease group

Primary Outcome Measures

Name	Time	Method
Difference in microbiome profile of small intestine samples between groups	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 Outcome Measures

Name	Time	Method
Difference in blood metabolome composition between groups	Baseline	Blood metabolome composition profile of Parkinson's Disease patients as compared to age-matched neurotypical controls, as determined by metabolomics analysis
Correlation between the observed small intestine microbiome profile and blood metabolome composition, including, in PD subjects, levodopa pharmacodynamics	Baseline	Small intestinal and blood pharmacodynamics of Levodopa as a function of small intestinal microbiota profiles, as determined by blood and small intestinal metabolomics and small intestinal whole metagenome shotgun profiling and appropriate statistical correlation methods

Trial Locations

Locations (1)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada