NCT06762028

Exploring the Relationship Between L-dopa Responsiveness and Small Intestinal Microbiome in Parkinson's Disease

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The investigators hypothesize that small intestinal (SI) microbiome biomarkers predict the responsiveness to oral levodopa/carbidopa in people with Parkinson's disease (PwPD). The investigators will analyze the bacterial species and function of bacterial pathways influencing the responsiveness of PwPD to oral L-dopa. The investigators will pursue this goal using a reliable capsule system (SIMBA capsule, Nimble Science, Calgary, AB) that suitably captures SI luminal fluid for multi-omics analysis.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DEVICE	SIMBA capsule	The small intestine microbiome aspiration (SIMBA) system is a single-use, ingestible passive capsule that allows for the non-invasive sampling of small intestinal contents. It is designed to open and adsorb intestinal content after having passed the acid stomach environment and to close mechanically before passing into the large bowel. It has distinct markers built in to allow radiographic tracking of its passage throughout the GI system.

Timeline

• Start date: 2025-02-01
• Primary completion: 2027-02-01
• Completion: 2027-07-01
• First posted: 2025-01-07
• Last updated: 2025-01-07