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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
Sponsor:
Collaborator:
MRM Health N.V.
Information provided by (Responsible Party):
Nimble Science Ltd.

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).

Condition or disease Intervention/treatment
Parkinson Disease Device: Fluid biopsy capsule Drug: Levodopa-Carbidopa Immediate Release

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).

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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
Estimated Study Start Date : February 19, 2024
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : September 2024


Group/Cohort Intervention/treatment
Healthy control (HC)
25 neurotypical controls, age-matched to the Parkinson's disease group
Device: Fluid biopsy capsule
Ingestion of two SIMBA capsules

Parkinson's disease (PD)
75 Parkinson's disease patients
Device: Fluid biopsy capsule
Ingestion of two SIMBA capsules

Drug: Levodopa-Carbidopa Immediate Release
Single dose, Levodopa-Carbidopa Immediate Release




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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


Biospecimen Retention:   Samples With DNA
Whole Blood sample, Stool sample, Fluid from small intestine


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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
  4. Able to swallow a size-00 capsule (23mm length) in OFF state Additional inclusion criteria for PD patients only
  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. Documented HIV infection, or any clinically significant systemic infection,
  11. 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
  12. Dementia in medical history or identified by a MMSE <24,
  13. Insulin-dependent diabetes mellitus,
  14. Current Psychosis episode by clinical judgement based on anamnesis
  15. Active significant impulse control disorder (by clinical judgement and based on interview and medical records)
  16. Pregnancy
  17. Alcohol or drug abuse
  18. Deep brain stimulation or Duodopa/Lecigon treatment.
  19. 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06003608


Contacts
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Contact: Davide Martino, MD PhD 403-210-8726 davide.martino@ucalgary.ca

Locations
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Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 1N4
Contact: Davide Martino, MD         
Sponsors and Collaborators
Nimble Science Ltd.
MRM Health N.V.
Investigators
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Principal Investigator: Davide Martino, MD PHD University of Calgary
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Responsible Party: Nimble Science Ltd.
ClinicalTrials.gov Identifier: NCT06003608    
Other Study ID Numbers: M007-PD-001
First Posted: August 22, 2023    Key Record Dates
Last Update Posted: February 5, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Levodopa
Carbidopa
Carbidopa, levodopa drug combination
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors
Adjuvants, Immunologic
Immunologic Factors
Dopamine Agonists