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

NCT ID: NCT06762028

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2027-07-01

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Interventions

SIMBA capsule

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 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)

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 (25mm length) in OFF state.

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

1. Any risk of capsule non-excretion related to intercurrent gastrointestinal conditions.

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.

3. History of oropharyngeal dysphagia, or other swallowing disorder with a risk of capsule aspiration, e.g., SDQ score > 4.

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.

5. Active cancer within 5 years.

6. Clinically significant immune deficiency (according to Investigator's judgement).

7. Antibiotic use (except for local use), ≤12 weeks prior to on-site study visit, or Fecal Microbiota Transplantation anytime in medical history.

8. Use of prebiotics, or probiotics ≤2 weeks prior to the on-site study visit.

9. Dementia in medical history.

10. Insulin-dependent diabetes mellitus.

11. Current Psychosis episode by clinical judgement based on anamnesis.

12. Pregnancy.

13. Alcohol or drug abuse.

14. Deep brain stimulation or Duodopa/Lecigon treatment.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Davide Martino

Role: CONTACT

davide.martino@ucalgary.ca

4032108726

Other Identifiers

POP24-11461

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

UCalgaryREB24-1779

Identifier Type: -

Identifier Source: org_study_id