Exploring the Relationship Between L-dopa Responsiveness and Small Intestinal Microbiome in Parkinson's Disease

NCT06762028 | Not Yet Recruiting

• 2 other identifiers: UCalgaryREB24-1779POP24-11461
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Keywords

SIMBA; small intestine; L-dopa

Outcome Measures

Primary Outcomes (1)

• 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).

  Same day of study visit

Secondary Outcomes (5)

• time latency to full "ON" state

  Same day of study visit

• Part 4 score of the MDS-UPDRS

  Same day of study visit

• Maximum observed plasma concentration of L-dopa (Cmax)

  Same day of study visit

• Time to maximum observed plasma concentration (Tmax)

  Same day of study visit

• Area under the L-dopa concentration-time curve (0-3 hours; AUC0-3 h)

  Same day as study visit

Interventions

SIMBA capsule DEVICE

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.

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Any patient with Parkinson disease fulfilling section criteria.

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• University of Calgary: lead

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Davide Martino

CONTACT

4032108726; davide.martino@ucalgary.ca

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 7, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 7, 2025

Record last verified: 2024-12