跳至主要内容
临床试验/NCT03968133
NCT03968133进行中(未招募)2 期

Treating Anxiety in Parkinson's Disease With a Multi-Strain Probiotic - a Randomized, Placebo-controlled Trial

University of British Columbia2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2020年12月10日最近更新:
适应症

试验速览

阶段
2 期
状态
进行中(未招募)
入组人数
61
试验地点
2
主要终点
Parkinson's Anxiety Scale (PAS)

研究概览

简要总结

This study evaluates the use of an oral multi-strain probiotic in the treatment of anxiety in individuals with Parkinson's Disease. Participants will be randomized to either 12-week multi-strain probiotic treatment or placebo.

详细描述

Parkinson's disease (PD) is a complex condition that carries a high burden of neuropsychiatric comorbidities. About a third of individuals living with Parkinson's disease have one or more anxiety disorders, resulting in lower quality of life, greater care dependency, and increased caregiver burden. Gastrointestinal dysfunction is very common in Parkinson's. Constipation is experienced by the vast majority of patients and often manifests years before onset of motor symptoms, symptoms suggestive of irritable bowel syndrome are also commonly found in PD. Increased intestinal permeability has been demonstrated in PD. Impaired intestinal barrier function can lead to chronic systemic low-grade inflammation, which has been strongly associated with mood disorders. Several lines of evidence suggest a link between the gut microbiome and Parkinson's disease.

The microbiome has been linked to anxiety both in human and animal studies. Several studies have found beneficial effects of probiotics on mood disorders in non-PD populations, including stress and depressive behaviour in animal models, and sad mood reactivity and major depressive disorder in humans. Specifically regarding anxiety, probiotics have shown benefits in several animal models; human probiotic trials have demonstrated improvements in psychological distress and anxiety in healthy controls, in mothers experiencing postpartum depression and anxiety and in individuals afflicted with IBS-related anxiety without PD.

In summary, given the high rate of anxiety in PD, the growing evidence that probiotics may improve anxiety and mood disorders in non-PD populations, and the strong links between the gut microbiome and PD, we will carry out a randomized, blinded, placebo-controlled study into the use of a multi-strain probiotic to improve anxiety and Parkinson's disease.

Recruitment: Approximately 72 participants will be randomized to either the probiotic intervention arm or placebo treatment. Participants will mainly be recruited from the Pacific Parkinson's Research Centre movement disorder clinic at the University of British Columbia in Vancouver.

Participants will receive a detailed description of the study and will need to provide informed consent for participation in the study. Participants will be screened for inclusion and exclusion criteria.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Parkinson's Anxiety Scale (PAS)

时间窗: 13 weeks

The PAS is a self reported 12-item scale that has three subscales: persistent anxiety, episodic anxiety, and avoidance behavior; It is rated using a Likert scale (0-4).

次要结局

  • Fatigue Severity Scale (FSS)(13 weeks)
  • Beck Depression Inventory (BDI)(13 weeks)
  • Parkinson's Disease Quality of Life Questionnaire (PDQ-39)(13 weeks)
  • Montreal Cognitive Assessment(13 weeks)
  • Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)(13 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Silke Cresswell

Associate Professor

University of British Columbia

研究点 (2)

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