- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06003608
Observational Small Intestine and Blood Fingerprint (SmIle) Study in Parkinson's Disease (SmIle)
February 2, 2024 updated by: Nimble Science Ltd.
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
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).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Davide Martino, MD PhD
- Phone Number: 403-210-8726
- Email: davide.martino@ucalgary.ca
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada, T2N 1N4
- Recruiting
- University of Calgary
-
Contact:
- Davide Martino, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
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.
Description
Inclusion Criteria
Subjects are eligible to be included in the study only if all of the following criteria apply:
- Males and females aged 50-85 years old at time of on-site visit
- Signed Informed consent
- Willing & able to comply with study procedures (including SIMBA capsule ingestion) and have study assessments performed
- Able to swallow a size-00 capsule (23mm length) in OFF state Additional inclusion criteria for PD patients only
- Diagnosis of idiopathic PD (Clinically Probable PD), including documented levodopa responsiveness
- 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:
- 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,
- 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,
- 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
- History of oropharyngeal dysphagia, or other swallowing disorder with a risk of capsule aspiration, e.g. SDQ score > 4,
- 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,
- Major genital and/or rectum prolapse,
- 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,
- Active cancer, including any prolactinoma, within 5 years (allowed: uncomplicated basal cell carcinoma and successfully removed carcinoma in situ),
- Clinically significant immune deficiency (according to Investigator's judgement),
- Documented HIV infection, or any clinically significant systemic infection,
- Antibiotic use (except for local use), use of prebiotics, or probiotics ≤12 weeks prior to on-site study visit, or Fecal Microbiota Transplantation anytime in medical history
- Dementia in medical history or identified by a MMSE <24,
- Insulin-dependent diabetes mellitus,
- Current Psychosis episode by clinical judgement based on anamnesis
- Active significant impulse control disorder (by clinical judgement and based on interview and medical records)
- Pregnancy
- Alcohol or drug abuse
- Deep brain stimulation or Duodopa/Lecigon treatment.
- Subject, according to investigator assessment, not expected to be able to comply with study procedures including SIMBA capsule recovery and SIBO breath test execution with - or without help (when home).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy control (HC)
25 neurotypical controls, age-matched to the Parkinson's disease group
|
Ingestion of two SIMBA capsules
|
Parkinson's disease (PD)
75 Parkinson's disease patients
|
Ingestion of two SIMBA capsules
Single dose, Levodopa-Carbidopa Immediate Release
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in blood metabolome composition between groups
Time Frame: Baseline
|
Blood metabolome composition profile of Parkinson's Disease patients as compared to age-matched neurotypical controls, as determined by metabolomics analysis
|
Baseline
|
Correlation between the observed small intestine microbiome profile and blood metabolome composition, including, in PD subjects, levodopa pharmacodynamics
Time Frame: Baseline
|
Small intestinal and blood pharmacodynamics of Levodopa as a function of small intestinal microbiota profiles, as determined by blood and small intestinal metabolomics and small intestinal whole metagenome shotgun profiling and appropriate statistical correlation methods
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Davide Martino, MD PHD, University of Calgary
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
February 19, 2024
Primary Completion (Estimated)
August 1, 2024
Study Completion (Estimated)
September 1, 2024
Study Registration Dates
First Submitted
August 2, 2023
First Submitted That Met QC Criteria
August 15, 2023
First Posted (Actual)
August 22, 2023
Study Record Updates
Last Update Posted (Estimated)
February 5, 2024
Last Update Submitted That Met QC Criteria
February 2, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Parkinson Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Immunologic Factors
- Dopamine Agonists
- Dopamine Agents
- Adjuvants, Immunologic
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Aromatic Amino Acid Decarboxylase Inhibitors
- Levodopa
- Carbidopa
- Carbidopa, levodopa drug combination
Other Study ID Numbers
- M007-PD-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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