Parkinson DiseaseSmIleNCT06003608
Observational Small Intestine and Blood Fingerprint (SmIle) Study in Parkinson's Disease
An observational study of Parkinson Disease, run by Nimble Science Ltd. at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Fluid biopsy capsule and Levodopa-Carbidopa Immediate Release
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 51 participants
- Where
- 1 siteCanada
- Study dates
- 19 Feb 2024to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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,
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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).
- Conditions
- Parkinson Disease
- Being tested
- Fluid biopsy capsule, Levodopa-Carbidopa Immediate Release
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid biopsy capsuleDevice
Ingestion of two SIMBA capsules
Levodopa-Carbidopa Immediate ReleaseDrug
Single dose, Levodopa-Carbidopa Immediate Release
| Study group | Role | What they receive |
|---|---|---|
| Healthy control (HC) | 25 neurotypical controls, age-matched to the Parkinson's disease group Receives: Device: Fluid biopsy capsule | |
| Parkinson's disease (PD) | 75 Parkinson's disease patients Receives: Device: Fluid biopsy capsule; Drug: Levodopa-Carbidopa Immediate Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in microbiome profile of small intestine samples between groups
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
Measured: Baseline
Secondary outcomes (2)
Difference in blood metabolome composition between groups
Blood metabolome composition profile of Parkinson's Disease patients as compared to age-matched neurotypical controls, as determined by metabolomics analysis
Measured: Baseline
Correlation between the observed small intestine microbiome profile and blood metabolome composition, including, in PD subjects, levodopa pharmacodynamics
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start19 Feb 2024
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Why it stopped: Study recruitment phase exceeded the time allotted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nimble Science Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MRM Health NV
- Responsible party
- Sponsor
- Investigators
- Davide Martino, MD PHD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06003608
- Sponsor's protocol ID
- M007-PD-001
- Acronym
- SmIle
- Status last verified
- Oct 2026
- First submitted
- 2 Aug 2023
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06003608
- Acronym / sponsor ID
- SmIle / M007-PD-001
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study recruitment phase exceeded the time allotted
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Nimble Science Ltd.Industry (pharma, biotech, devices)
- Collaborators
- MRM Health NV
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy control (HC) | – | Device: Fluid biopsy capsule25 neurotypical controls, age-matched to the Parkinson's disease group |
| Parkinson's disease (PD) | – | Device: Fluid biopsy capsule, Drug: Levodopa-Carbidopa Immediate Release75 Parkinson's disease patients |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (20 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluid biopsy capsuleIngestion of two SIMBA capsules | Device | Healthy control (HC), Parkinson's disease (PD) |
| Levodopa-Carbidopa Immediate ReleaseSingle dose, Levodopa-Carbidopa Immediate Release | Drug | Parkinson's disease (PD) |
Primary outcome
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
2 secondary outcomes
Difference in blood metabolome composition between groups
Time frame: Baseline
Correlation between the observed small intestine microbiome profile and blood metabolome composition, including, in PD subjects, levodopa pharmacodynamics
Time frame: Baseline
Results and safety
The study was stopped early (reason given: Study recruitment phase exceeded the time allotted). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Davide Martino, MD PHD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Nimble Science Ltd. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study recruitment phase exceeded the time allotted). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in microbiome profile of small intestine samples between groups (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.