NCT06003608

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Nimble Science Ltd. · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Accepted

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).

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DEVICE	Fluid biopsy capsule	Ingestion of two SIMBA capsules
DRUG	Levodopa-Carbidopa Immediate Release	Single dose, Levodopa-Carbidopa Immediate Release

Timeline

• Start date: 2024-02-19
• Primary completion: 2025-02-01
• Completion: 2025-02-01
• First posted: 2023-08-22
• Last updated: 2025-01-31

Locations

1 site across 1 country: Canada