Parkinson DiseaseLENSERNCT06762028
Exploring the Relationship Between L-dopa Responsiveness and Small Intestinal Microbiome in Parkinson's Disease
An observational study of Parkinson Disease, run by University of Calgary.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- SIMBA capsule
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 1 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Any patient with Parkinson disease fulfilling section criteria.
Who may be able to join
- Males and females aged 50-85 years old at time of on-site visit. (ages 81-85 will be assessed on a per case basis by the principal investigator)
- 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 (25mm length) in OFF state.
- 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
- Any risk of capsule non-excretion related to intercurrent gastrointestinal conditions.
- 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.
- History of oropharyngeal dysphagia, or other swallowing disorder with a risk of capsule aspiration, e.g., SDQ score > 4.
- 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 within 5 years.
- Clinically significant immune deficiency (according to Investigator's judgement).
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- Antibiotic use (except for local use), ≤12 weeks prior to on-site study visit, or Fecal Microbiota Transplantation anytime in medical history.
- Use of prebiotics, or probiotics ≤2 weeks prior to the on-site study visit.
- Dementia in medical history.
- Insulin-dependent diabetes mellitus.
- Current Psychosis episode by clinical judgement based on anamnesis.
- Pregnancy.
- Alcohol or drug abuse.
- Deep brain stimulation or Duodopa/Lecigon treatment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Parkinson Disease
- Being tested
- SIMBA capsule
- Keywords
- SIMBA, small intestine, L-dopa
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIMBA capsuleDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Same day of study visit
Secondary outcomes (5)
time latency to full "ON" state
Temporal period between L-dopa ingestion and full "ON" state during a single L-dopa challenge test
Measured: Same day of study visit
Part 4 score of the MDS-UPDRS
Motor fluctuations and L-dopa-induced dyskinesia
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Same day as study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
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.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762028
- Sponsor's protocol ID
- UCalgaryREB24-1779
- Other IDs
- POP24-11461
- Acronym
- LENSER
- Status last verified
- Dec 2024
- First submitted
- 20 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Relationship Between L-dopa Responsiveness and Small Intestinal Microbiome in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06762028
- Acronym / sponsor ID
- LENSER / UCalgaryREB24-1779
- Conditions
- Parkinson Disease
- Keywords
- SIMBA, small intestine, L-dopa
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 7 Jan 2025 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient with Parkinson disease fulfilling section criteria.
Key inclusion criteria (6 listed)
- Males and females aged 50-85 years old at time of on-site visit. (ages 81-85 will be assessed on a per case basis by the principal investigator)
- 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 (25mm length) in OFF state.
- Diagnosis of idiopathic PD (Clinically Probable PD), including documented levodopa responsiveness.
Key exclusion criteria (14 listed)
- Any risk of capsule non-excretion related to intercurrent gastrointestinal conditions.
- 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.
- History of oropharyngeal dysphagia, or other swallowing disorder with a risk of capsule aspiration, e.g., SDQ score > 4.
- 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 within 5 years.
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 |
|---|---|---|
| SIMBA capsuleThe 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. | Device | – |
Primary outcome
Change of Part 3 score of the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) on L-dopa challenge test
Time frame: Same day of study visit
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).
5 secondary outcomes
time latency to full "ON" state
Time frame: Same day of study visit
Part 4 score of the MDS-UPDRS
Time frame: Same day of study visit
Maximum observed plasma concentration of L-dopa (Cmax)
Time frame: Same day of study visit
Time to maximum observed plasma concentration (Tmax)
Time frame: Same day of study visit
Area under the L-dopa concentration-time curve (0-3 hours; AUC0-3 h)
Time frame: Same day as study visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by University of Calgary.
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 6 inclusion and 14 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: opening soon, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Davide Martino (4032108726, davide.martino@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Part 3 score of the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) on L-dopa challenge test (time frame: Same day of study visit). 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 7 Jan 2025.