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| ID | Type | Description | Link |
|---|---|---|---|
| POP24-11461 | Other Grant/Funding Number | Weston Family Foundation |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIMBA capsule | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Part 3 score of the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) on L-dopa challenge test | The primary outcome is the acute responsiveness to an immediate release L-dopa/carbidopa or L-dopa/benserazide dose, quantified as the percent change from pre-intake ("OFF" state) to full "ON" state of the Part 3 score of the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS). | Same day of study visit |
| Measure | Description | Time Frame |
|---|---|---|
| time latency to full "ON" state | Temporal period between L-dopa ingestion and full "ON" state during a single L-dopa challenge test | Same day of study visit |
| Part 4 score of the MDS-UPDRS | Motor fluctuations and L-dopa-induced dyskinesia |
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Inclusion Criteria:
Exclusion Criteria:
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Any patient with Parkinson disease fulfilling section criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Davide Martino | Contact | 4032108726 | davide.martino@ucalgary.ca |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Same day of study visit |
| Maximum observed plasma concentration of L-dopa (Cmax) | The investigators will determine maximum observed plasma concentration (Cmax) directly from serial samples. | Same day of study visit |
| Time to maximum observed plasma concentration (Tmax) | The investigators will determine time to maximum observed plasma concentration (Tmax) directly from serial samples. | Same day of study visit |
| Area under the L-dopa concentration-time curve (0-3 hours; AUC0-3 h) | The investigators will determine the area under the L-dopa plasma concentration-time curve (0-3 hours; AUC0-3 h). | Same day as study visit |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |