Exploring the Relationship Between L-dopa Responsiveness and Small Intestinal Microbiome in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Change of Part 3 score of the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) on L-dopa challenge test
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 >
- •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.
- •Alcohol or drug abuse.
- •Deep brain stimulation or Duodopa/Lecigon treatment.
结局指标
主要结局
Change of Part 3 score of the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) on L-dopa challenge test
时间窗: Same day of study visit
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).
次要结局
- 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)