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

NCT06003608 | Active Not Recruiting DMC

• 1 other identifier: M007-PD-001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline

Secondary Outcomes (2)

• Difference in blood metabolome composition between groups

  Baseline

• Correlation between the observed small intestine microbiome profile and blood metabolome composition, including, in PD subjects, levodopa pharmacodynamics

  Baseline

Study Arms (2)

Healthy control (HC)

25 neurotypical controls, age-matched to the Parkinson's disease group

Device: Fluid biopsy capsule

Parkinson's disease (PD)

75 Parkinson's disease patients

Device: Fluid biopsy capsule; Drug: Levodopa-Carbidopa Immediate Release

Interventions

Fluid biopsy capsule DEVICE

Ingestion of two SIMBA capsules

Healthy control (HC); Parkinson's disease (PD)

Levodopa-Carbidopa Immediate Release DRUG

Single dose, Levodopa-Carbidopa Immediate Release

Parkinson's disease (PD)

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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,
• 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)

Sponsors & Collaborators

• Nimble Science Ltd.: lead
• MRM Health NV: collaborator

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood sample, Stool sample, Fluid from small intestine

MeSH Terms

Conditions

Parkinson Disease

Interventions

carbidopa, levodopa drug combination

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Davide Martino, MD PHD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 22, 2023
• Study Start: February 19, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)