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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

NCT06003608•Nimble Science Ltd.

View on ClinicalTrials.gov

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).

Eligibility

Age

50 - 85 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Subjects are eligible to be included in the study only if all of the following criteria apply:
•1. Males and females aged 50-85 years old at time of on-site visit
•2. Signed Informed consent
•3. Willing \& able to comply with study procedures (including SIMBA capsule ingestion) and have study assessments performed
•5. Diagnosis of idiopathic PD (Clinically Probable PD), including documented levodopa responsiveness
•6. Treatment with an immediate release levodopa formulation during the day at a stable dose for at least 2 months prior to enrollment

Exclusion Criteria

•Subjects are excluded from the study if any of the following criteria apply:
•1. Any risk of capsule non-excretion, including, e.g., prior gastrointestinal disease, surgery, or radiation treatment which, in the Investigator's opinion, would lead to intestinal structuring or obstruction, achalasia, eosinophilic esophagitis, any inflammatory bowel disease (IBD), cancer diagnosis or treatment within the past year, or previous esophageal, gastric, small intestinal, or colonic surgery; appendectomy or cholecystectomy more than 3 months prior to on-site study visit are acceptable,
•2. Use of any medications in the week prior to the on-site study visit, unless part of regular treatment, that could substantially alter gastrointestinal motor function (e.g., opioids, prokinetics, anticholinergics); laxative use is allowed provided that it is kept unchanged in the week prior to the study visit. PPIs are allowed provided a wash-out period of 48 hours is respected before swallowing the SIMBA capsules and PPI treatment is resumed only 4 hours thereafter,
•3. Any contraindication for using domperidone, including a long QT interval, concomitant use of QT prolonging drugs, any risk of significant electrolyte abnormality, known hypersensitivity, known liver impairment or significant (e.g. unstable) cardiac disease (see label) putting the subject at significant risk according to the investigator's clinical judgement
•4. History of oropharyngeal dysphagia, or other swallowing disorder with a risk of capsule aspiration, e.g. SDQ score \> 4,
•5. Any concomitant PD treatment, including any dopamine agonist and MAO-B inhibitor, except (for PD patients only) an immediate release levodopa formulation during the day (required per inclusion criterion), the concomitant use of a decarboxylase inhibitor and the use of a controlled release levodopa formulation at bedtime,
•6. Major genital and/or rectum prolapse,
•7. Any concomitant or previous treatment (\<2 months from on-site study visit) with significant anti-inflammatory or immune suppressant medication, e.g. DMARDs, biologicals or systemic corticosteroids, except non-chronic PRN use of an NSAID and/or 5-ASA (mesalazine) treatment,
•8. Active cancer, including any prolactinoma, within 5 years (allowed: uncomplicated basal cell carcinoma and successfully removed carcinoma in situ),
•9. Clinically significant immune deficiency (according to Investigator's judgement),
+10 more criteria

Locations (1)

University of Calgary

Calgary, Alberta, Canada

Key Dates

Start Date

February 19, 2024

Primary Completion Date

February 1, 2025

Completion Date

February 1, 2025

Last Updated

January 31, 2025

Enrollment

100

ESTIMATED participants

Conditions

Parkinson Disease

Interventions

Fluid biopsy capsule

DEVICE

Levodopa-Carbidopa Immediate Release

DRUG

[18F]F-DOPA Imaging in Patients With Autonomic Failure

NCT04246437

Autonomic FailurePure Autonomic Failure+3 more

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RECRUITINGNA

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

NCT06692920

Parkinson Disease

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 31, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

[18F]F-DOPA Imaging in Patients With Autonomic Failure

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

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