Probiotic Treatment for Depression and Associated Mood Disorders in Parkinson's Disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Inventory of Depressive Symptomatology - Clinician-Rated (IDS-C)
研究概览
简要总结
This study evaluates the use of an oral multi-strain probiotic in the treatment of depression in individuals with Parkinson's Disease. Participants will be randomized to either a 12-week multi-strain probiotic treatment or placebo intervention.
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 PD have one or more depressive disorders, resulting in lower quality of life, greater care dependency, and increased caregiver burden. Gastrointestinal dysfunction is also very common in PD. Constipation is experienced by the vast majority of patients and often manifests years before onset of motor symptoms. Symptoms suggestive of irritable bowel syndrome (IBS) 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 PD.
The microbiome has been linked to depression 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 (MDD) in humans.
In summary, given the high rate of depression in PD, the growing evidence that probiotics may improve depression and mood disorders in non-PD populations, and the strong links between the gut microbiome and PD, we will carry out a randomized, triple-blinded, placebo-controlled study into the use of a multi-strain probiotic to improve depression and PD.
Recruitment: Approximately 60 participants will be randomized to either the probiotic intervention arm or the placebo intervention arm. Participants will mainly be recruited from the Pacific Parkinson's Research Centre (PPRC) Movement Disorder Clinic at the University of British Columbia (UBC) 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, which include completing screening questionnaires and reviewing medications/medical history.
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
- 否
入选标准
- •Confirmed diagnosis of Parkinson's disease based on UK Brain Bank criteria
- •Between the ages of 40-80 years
- •Mild to Moderate PD (Hoehn and Yahr stage between 1-3 in the "ON" state)
- •Mild to moderate depression (BDI-II score of 14-28 in the "ON" state)
- •Women of childbearing potential must agree to use a medically approved method of birth control (e.g., hormonal contraceptives, intrauterine devices, vasectomy/tubal litigation, barrier methods and double barrier method) and must have negative pregnancy test results at screening and baseline
- •Willingness to maintain current physical activity levels during study period
- •English proficiency
排除标准
- •Atypical Parkinsonism
- •Active suicidality
- •Active psychosis
- •Cognitive score (MoCA) of < 21 in the "ON" state
- •Severe depression (BDI-II score > 28 in the "ON" state)
- •Probiotic, Saccharomyces boulardii and/or antibiotic use in the past 3 months (yogurt, kefir, and other probiotic-containing foods are allowed)
- •The use of natural health products that affect depression (e.g., St. John's Wort, passion flower, gaba, 5-htp, kava, bacopa, efa's)
- •Change in the schedule of concurrent psychotherapy or brain stimulation for the treatment of mood or anxiety disorders in the last 4 weeks
- •Change in antidepressant or anxiolytic medication (including benzodiazepines) within the last 4 weeks
- •Change in Parkinson's medication within the last 2 weeks
- •Neurological disease other than PD, including Alzheimer's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, a brain tumour, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma
- •A significant immune-compromised condition due to either a health condition or use of an immune suppressant (e.g., AIDS, lymphoma, chemotherapy treatment, patients undergoing long-term systemic corticosteroid or immunosuppressant treatment)
- •A known bleeding disorder
- •Current illness (e.g., a cold or flu-like symptoms) and infections (e.g., hepatitis, HIV, gastroenteritis, fungal, or parasitic infections)
- •Allergy to corn starch or corn
- •Concurrent treatment for Parkinson's disease with Duodopa
- •Change in Deep Brain Stimulation (DBS) stimulation parameters in the last 4 weeks
- •New onset of significant psychiatric symptoms following DBS procedure that are considered likely related
- •Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
- •Unstable medical conditions or serious disease/conditions (e.g., cancer undergoing active treatment, poorly controlled diabetes)
- •Drug and/or substance abuse
- •The patient, in the opinion of the Investigator, is unable to adhere to the requirements of the study. This includes any patient who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a significant language barrier or cognitive impairment
研究组 & 干预措施
Placebo
Placebo (maize starch, maltodextrin, vegetable protein, magnesium sulphate, manganese sulphate)
干预措施: Placebo (Dietary Supplement)
Probiotic
Ecologic® BARRIER 849 (Maize starch, maltodextrin, vegetable protein, potassium chloride, +/- probiotic bacteria (B. bifidum W23, B. lactis W51, B. lactis W52, L. acidophilus W37, L. brevis W63, L. casei W56, L. salivarius W24, Lc. lactis W19, Lc. lactis W58; ≥ 2,5*10^9 colony forming unit (CFU)/g), magnesium sulphate, manganese sulphate.) sachet, two times daily dosing for a total of 2 grams (viable cell count of 2.5 × 10^9 CFU/gram) per day.
干预措施: Probiotic (Dietary Supplement)
结局指标
主要结局
Inventory of Depressive Symptomatology - Clinician-Rated (IDS-C)
时间窗: 13 weeks
The Inventory for Depressive Symptomatology is a measure of depressive signs and symptoms administered by a trained clinician. The score range is 0-84 points, with a higher score indicating greater levels of depressive symptomatology.
Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)
时间窗: 13 weeks
QIDS-SR is a 16-item, self-administered questionnaire used to assess the severity of depressive symptoms over the past 7 days, based on DSM-IV criteria. QIDS-SR is a shortened version of IDS-C, but QIDS-SR is self-rated (filled in the form of a questionnaire) and IDS-C is clinician-rated (administered as a clinical assessment), so using both assessments allows us to incorporate both self-rated and clinician-rated measures. The score range is 0-27 points, with a higher score indicating greater levels of depressive symptomatology.
Beck Depression Inventory, 2nd Edition (BDI-II)
时间窗: 13 weeks
The Beck Depression Inventory is a self-reported 21-question multiple-choice self-report inventory on a scale from 0-63. A higher score indicates greater characteristic attitudes and symptoms of depression. BDI-II is also used as a screening item for mild to moderate depression for this study.
次要结局
- Parkinson's Disease Quality of Life Questionnaire (PDQ-39)(13 weeks)
- Fatigue Severity Scale (FSS)(13 weeks)
- Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)(13 weeks)
- Parkinson's Anxiety Scale (PAS)(13 weeks)
- Montreal Cognitive Assessment (MoCA)(13 weeks)
- Parkinson's Disease - Cognitive Rating Scale (PD-CRS)(13 weeks)
- Parkinson's Disease - Cognitive Functional Rating Scale (PD-CFRS)(13 weeks)
研究者
Silke Cresswell
Associate Professor
University of British Columbia