Observational Small Intestine and Blood Fingerprint (SmIle) Study in Parkinson's Disease (SmIle)
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ClinicalTrials.gov Identifier: NCT06003608 |
Recruitment Status :
Recruiting
First Posted : August 22, 2023
Last Update Posted : February 5, 2024
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Sponsor:
Nimble Science Ltd.
Collaborator:
MRM Health N.V.
Information provided by (Responsible Party):
Nimble Science Ltd.
Tracking Information | |||||
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First Submitted Date | August 2, 2023 | ||||
First Posted Date | August 22, 2023 | ||||
Last Update Posted Date | February 5, 2024 | ||||
Estimated Study Start Date | February 19, 2024 | ||||
Estimated Primary Completion Date | August 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Observational Small Intestine and Blood Fingerprint (SmIle) Study in Parkinson's Disease | ||||
Official Title | 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 | ||||
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 Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Cross-Sectional |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Retention: Samples With DNA Description: Whole Blood sample, Stool sample, Fluid from small intestine
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Sampling Method | Probability Sample | ||||
Study Population | Eligibility will be determined based on information reported by the subject and the results of the screening assessments (physical exam, etc). Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as protocol waivers or exemptions, is not permitted. | ||||
Condition | Parkinson Disease | ||||
Intervention |
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
100 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | September 2024 | ||||
Estimated Primary Completion Date | August 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria Subjects are eligible to be included in the study only if all of the following criteria apply:
Exclusion Criteria Subjects are excluded from the study if any of the following criteria apply:
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Sex/Gender |
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Ages | 50 Years to 85 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts |
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Listed Location Countries | Canada | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT06003608 | ||||
Other Study ID Numbers | M007-PD-001 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Current Responsible Party | Nimble Science Ltd. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor | Nimble Science Ltd. | ||||
Original Study Sponsor | Same as current | ||||
Collaborators | MRM Health N.V. | ||||
Investigators |
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PRS Account | Nimble Science Ltd. | ||||
Verification Date | February 2024 |