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Not yet recruiting NCT06762028

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

— Observational Parkinson Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SIMBA capsule.
Who it may be relevant to
Registry conditions: Parkinson Disease. Basic parameters: 50 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device 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.

Primary outcome measures

  • 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]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06762028 · UCalgaryREB24-1779 · POP24-11461

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗