Probiotics and the Microbiome: Clinical Intervention Trial for Anxiety and Depression
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Depression Anxiety and Stress Scale (DASS) - Time 1 (we are assessing change over time)
研究概览
简要总结
The proposed project will investigate the effects of probiotics on anxiety and associated psychological and physiological factors in humans. The therapeutic potential of probiotics for reducing anxiety and other factors associated with a disrupted microbiome will be assessed in a double-blind placebo-crossover design. Based on the research findings to date, it is hypothesized that probiotics will reduce anxiety and depressive symptoms.
详细描述
Purpose
The human microbiome, also known as microflora, is comprised of the bacterial colonies of the body. Although bacteria are commonly associated with illness, there are good bacteria known as probiotic bacteria that grow naturally in the microbiome of the human gut. Probiotic bacteria are live microorganisms and consist of approximately 400 different bacterial strains that support life in their host organism. The gut microbiome, also known as intestinal flora, plays a role in normal human development, digestion, body weight, nutrition, and immune system regulation, in addition to influencing various neurological functions. It has been found that environmental factors including antibiotics, illness, stress, and diet can alter an individual's microbiome through their effects on probiotic bacteria situated in the gut microflora.
Although probiotic bacteria grow naturally in the human gut, acquisition of the gut microbiome varies in each individual depending on various factors, including birth method and early diet. Research suggests that newborns' first exposure to bacteria and acquisition of the first components of their microbiome takes place during birth. Infants acquire their mothers' bacteria as they pass through the vaginal canal during childbirth. Research indicates that, for this reason, children born through cesarean section have a less diverse microbiome (Dominguez-Bello, Costello, Contreras, Magris, Hidalgo, Fierer, & Knight, 2010). Research also suggests that following birth, infants continue to acquire their gut microbiome in the first two years of life under the influence of dietary nutrition. For example, in a study of six breast-fed and six formula fed infants, those who consumed a specially enriched formula that contained both prebiotics (substances that feed probiotics) and a variety of probiotic bacteria had a much more diverse intestinal flora than those who received breast milk (Harmsen, Wildeboer-Veloo, Raangs, Wagendorp, Klijn, Bindels, & Welling, 2000). Please note that this study does not negate the benefits of breast milk and was intended to assess the effect of heightened prebiotic and probiotic concentrations in a baby formula that was chemically similar to breast milk.
Because probiotic bacteria are acquired naturally from environmental sources in addition to growing normally in the human body, it is safe for humans to consume probiotics. Furthermore, Health Canada has labeled probiotics a natural health product (NHP) safe for human consumption. Common foods we eat each day contain probiotic bacteria that enrich our intestinal flora. For example, yogurt and cheese contain probiotic bacteria. There has been a recent upsurge in interest on probiotics amongst researchers as the positive effects of probiotics on the gut microbiome and recognition of their great therapeutic potential for a wide variety of conditions increases.
The Microbiome and Physical Health
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •I have a valid email address that I check routinely and daily access to the internet.
- •I experience symptoms of anxiety and/or depression.
- •I am over the age of
- •I am within driving distance of Wolfville, Kingston-Greenwood, or Halifax, Nova Scotia, and would be able to come to Wolfville or Halifax for appointments with the researchers. OR I am not within driving distance of Wolfville, Nova Scotia or Halifax Nova Scotia, but am a resident of Canada and would be available for telephone or online conference calls.
排除标准
- •I am a University/College professor or student.
- •I have one or more of the following diagnosed conditions: Cancer, Crohn's disease or ulcerative colitis, Multiple sclerosis, Lupus, Addison's Disease or other form of adrenal insufficiency
- •I am currently taking antibiotics or probiotic capsules.*
- •I have diagnosed HIV/AIDS.
- •I am currently undergoing chemotherapy
研究组 & 干预措施
Probiotics
400mg probiotic capsule taken once daily for ten weeks
干预措施: Probiotics (Other)
Placebo (rice flour)
400mg placebo capsule containing rice flour taken once daily for ten weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Depression Anxiety and Stress Scale (DASS) - Time 1 (we are assessing change over time)
时间窗: Baseline (at first meeting)
A self-report questionnaire that assesses current symptoms of depression, anxiety, and feelings related to stress. Note that this measure is completed by participants at three different time points in order to assess change in symptoms across time points.
Depression Anxiety and Stress Scale (DASS) - Time 2 (we are assessing change over time)
时间窗: administered at 10 weeks
A self-report questionnaire that assesses current symptoms of depression, anxiety, and feelings related to stress. Note that this measure is completed by participants at three different time points in order to assess change in symptoms across time points.
Depression Anxiety and Stress Scale (DASS) - Time 3 (we are assessing change over time)
时间窗: Administered at 22 weeks (i.e., the end of the study)
A self-report questionnaire that assesses current symptoms of depression, anxiety, and feelings related to stress. Note that this measure is completed by participants at three different time points in order to assess change in symptoms across time points.
Anxiety Sensitivity Index (ASI) - Time 1 (we are assessing change over time)
时间窗: Baseline (at first meeting)
A self-report questionnaire that assesses anxiety sensitivity -- the degree to which an individual focuses on and notices (and avoids) physical changes related to anxiety. Note that this measure is completed by participants at three different time points in order to assess change in anxiety sensitivity across time points.
Anxiety Sensitivity Index (ASI) - Time 2 (we are assessing change over time)
时间窗: administered at 10 weeks
A self-report questionnaire that assesses anxiety sensitivity -- the degree to which an individual focuses on and notices (and avoids) physical changes related to anxiety. Note that this measure is completed by participants at three different time points in order to assess change in anxiety sensitivity across time points.
Anxiety Sensitivity Index (ASI) - Time 3 (we are assessing change over time)
时间窗: administered at 22 weeks
A self-report questionnaire that assesses anxiety sensitivity -- the degree to which an individual focuses on and notices (and avoids) physical changes related to anxiety. Note that this measure is completed by participants at three different time points in order to assess change in anxiety sensitivity across time points.
次要结局
未报告次要终点
