NCT06762028Not yet recruiting
Exploring the Relationship Between L-dopa Responsiveness and Small Intestinal Microbiome in Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 7 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 20 Dec 2024
- Start date
- 1 Feb 2025
- Primary completion date
- 1 Feb 2027
- Lead sponsor
- University of Calgary
- Diseases
- Parkinson disease
- NCT number
- NCT06762028
What you commit to
- Study type: Observational
- Planned participants: 100
- From 1 Feb 2025 to the primary completion date, 1 Feb 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
- 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.
- Alcohol or drug abuse.
Other illness
- Any risk of capsule non-excretion related to intercurrent gastrointestinal conditions.
- History of oropharyngeal dysphagia, or other swallowing disorder with a risk of capsule aspiration, e.g., SDQ score \> 4.
- Active cancer within 5 years.
- Dementia in medical history.
- Insulin-dependent diabetes mellitus.
Other
- Clinically significant immune deficiency (according to Investigator's judgement).
- Current Psychosis episode by clinical judgement based on anamnesis.
- Pregnancy.
- Deep brain stimulation or Duodopa/Lecigon treatment.
Who the study is looking for
- 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.
Age in the registry: 50 years to 85 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.