Pilot-study: Probiotics and the Gut Brain Axis- Do Probiotics Interact With the Vagal Nerve? ProBIO-HRV-study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Change of Vagal function
研究概览
简要总结
The purpose of this study is to investigate the effects of a multispecies probiotic on the function of the vagal nerve in patients with major depression and healthy participants in a single-center, randomized, placebo-controlled trial.
详细描述
After being informed about the study and potential risks, all participants giving written informed consent will be screened for eligibility for study entry and will be randomized in a double-blind manner to receive either a multistrain probiotic or a placebo for 3 months. At entry, 1 week after inclusion, 4 weeks after inclusion and 3 months (end of study) vagal activity will be measured using a 24hr electrocardiogram.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •informed consenct
- •confirmed diagnosis of depression according to ICD-10 or DSM-V
- •age between 18 and 65 years
排除标准
- •Suicidality
- •no informed consent or no ability to provide consent
- •cardiovascular disease
- •pregnancy, breastfeeding
- •alcohol or drug dependency
- •other severe psychiatric or organic conditions (epilepsy, brain tumor, recent surgery)
- •malignant diseases
- •dementia (MMST<20)
- •severe autoimmune-disorder or immunosuppression (systemic lupus, HIV, multiple sclerosis)
- •antibiotic therapy in the last month
- •misuse of laxative
- •acute infections
- •diarrhoea
- •gastrointestinal surgeries (except appendectomy)
- •no probiotic intake in the last 6 months
- •no regular intake of other supplements, probiotics or antibiotics during the study
研究组 & 干预措施
Participants with Major Depression receiving a multi-strain probiotic
Participants with Major Depression receiving a multi-strain probiotic
干预措施: Multispecies-Probiotic (Dietary Supplement)
Participants mit Major Depression receiving a placebo
Participants mit Major Depression receiving a placebo
干预措施: Placebo Supplement (Dietary Supplement)
Healthy volunteers receiving a multi-strain probiotic
Healthy volunteers receiving a multi-strain probiotic
干预措施: Multispecies-Probiotic (Dietary Supplement)
Healthy volunteers receiving a placebo
Healthy volunteers receiving a placebo
干预措施: Placebo Supplement (Dietary Supplement)
结局指标
主要结局
Change of Vagal function
时间窗: 4 measurements with 24-hr heart rate variability at study entry, one week after, 1 month after and after 3 months
Heart rate variability parameters (logRSA; SDNN)
次要结局
- Change in Hamilton Scale for Depression (HAMD)(4 time points at study entry, one week after, 1 month after and 3 months (completion of the study))
- Change in Pittsburgh Sleep Quality Inventory (PSQI)(at study entry, after 7 days, after 4 weeks and after 3 months)
- Change of Interleukine-6 (IL-6)(4 time points at study entry, one week after, 1 month after and 3 months (completion of the study))
- Change of Gut microbiome analysis(4 time points at study entry, one week after, 1 month after and 3 months (completion of the study))
- Mini-international neuropsychiatric interview (M.I.N.I.)(at study entry)
- Change in Adult Attachment Scale(at study entry, after 7 days, after 4 weeks and after 3 months)
- Change in "Wiener Ernährungsprotokoll"(at study entry, after 7 days, after 4 weeks and after 3 months)
- Change of Oxytocin(4 time points at study entry, one week after, 1 month after and 3 months (completion of the study))
- Change of C-reactive protein (CRP)(4 time points at study entry, one week after, 1 month after and 3 months (completion of the study))
- Change of Body mass index(4 time points at study entry, one week after, 1 month after and 3 months (completion of the study))
- Change in International Physical Activity Questionnaire(at study entry, after 7 days, after 4 weeks and after 3 months)
- Beck Depression Inventory (BDI)(Change in 4 time points at study entry, one week after, 1 month after and 3 months (completion of the study))