The Role of the Microbiota-gut-brain Axis in Brain Development and Mental Health: Behavioural
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Changes in self reported indices of anxiety.
研究概览
简要总结
A behavioural study of the microbiota-gut-brain axis in brain development and mental health
详细描述
Research suggests that modifying microbial ecology therapeutically via the intake of so-called 'psychobiotics' could help reduce stress responses and symptoms of anxiety and depression (Burnet & Cowen, 2013; Dinan, Stanton, & Cryan, 2013; Tang, Reddy, & Saier, 2014). The term psychobiotics refers to both, beneficial gut bacteria (probiotics), as well as prebiotics, which enhance the growth of beneficial gut bacteria (Sarkar et al., 2016). In a recent study, Schmidt and colleagues explored the effects of prebiotics on the secretion of the stress hormone cortisol and emotional processing in healthy volunteers (Schmidt et al., 2015). They found that cortical awakening response was significantly lower after BimunoÒ-galacto-oligosaccharides (Bimuno) intake over 4 weeks compared with placebo. Moreover, participants exhibited decreased attentional vigilance to negative information in a dot-probe task. Given that anxious people show increased biases towards negative information (Bar-Haim, Lamy, Pergamin, Bakermans-Kranenburg, & van, 2007), this suggests that prebiotic intake may be useful in modifying anxiety-related cognitive mechanisms.
These findings will be extended to a sample of late adolescents in order to investigate how prebiotic intake for 4 weeks affects cognitive functioning, psychological well-being and gut microbiota a sample of 60 undergraduate students (aged 18-25 years).
At time 1 (pre-assessment), participants in both groups will undergo comprehensive behavioural and psychological testing to establish baseline measures of cognitive functioning and psychological well-being (such as anxiety levels) and asked to collect a stool sample at home for 16s rRNA sequencing of the microbiome. Group 1 will then receive a daily dosage of a galactooligosaccharide (GOS) prebiotic over 4 weeks, whereas group 2 will receive a placebo over the same period. At time 2 (post-assessment), both groups will again undergo cognitive and psychological testing and stool sampling.
Hypothesis
It is predicted that the treatment group (GOS) will show improvements in behavioural indices of emotion regulation (e.g. dot probe task) and in self reported psychological measures related to emotion regulation (e.g. anxiety) in comparison to the placebo group. Changes/differences in gut microbiome samples will be explored.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged between 18-25
排除标准
- •Clinical levels of anxiety and/ or co-morbid diagnoses (e.g. depression)
- •Current or previous neurological disorders
- •Current or previous psychiatric disorders
- •Current or previous gastrointestinal disorders
- •Current or previous endocrine disorders
- •Antibiotic use 3 months prior to the study
- •Regular use of pre- and probiotics, including 3 months prior to the study
- •Vegan diets
结局指标
主要结局
Changes in self reported indices of anxiety.
时间窗: 4 weeks
Changes in self reported anxiety as measured by the Trait Anxiety subscale of the State-Trait Anxiety Inventory (Spielberger, 1978) in the prebiotic group compared to placebo group. For this inventory, a lower overall score is the desired outcome.
Changes in self reported indices of anxiety 3.
时间窗: 4 weeks
Changes in self reported social anxiety measured by Social Anxiety Scales (La G reca 1999) in the prebiotic group compared to placebo group. For this scale, a lower overall score is the desired outcome.
Changes in self reported emotion regulation (Thought control ability).
时间窗: 4 weeks
Changes in the prebiotic group compared to placebo for Thought control ability (Luciano et al 2005). For this questionnaire, a higher overall score is the desired outcome.
Changes in self reported indices of anxiety 2.
时间窗: 4 weeks
Changes in self reported anxiety as measured by the State Anxiety subscale of the State-Trait Anxiety Inventory (Spielberger, 1978) in the prebiotic group compared to placebo group. For this inventory, a lower overall score is the desired outcome.
Changes in self reported emotion regulation (Emotion regulation strategies).
时间窗: 4 weeks
Changes in the prebiotic group compared to placebo for emotion regulation strategies (Gross \& John, 2003). For this questionnaire, a higher overall score is the desired outcome.
Changes in self reported mood
时间窗: 4 weeks
Changes in the prebiotic group compared to placebo for mood and feelings as measured by the mood and feelings questionnaire (Angold etal., 1995). A lower overall score is the desired outcome.
Behavioural indices of emotion regulation
时间窗: 4 weeks
Changes in performance on dot-probe task measured as attentional bias to emotional stimuli in milliseconds in the prebiotic group compared to placebo. Increased attentional bias to positive stimuli and/or decreased attentional bias to negative stimuli is the desired outcome.
Changes in self reported depression.
时间窗: 4 weeks
Changes in the prebiotic group compared to placebo for depression as measured by the Depression inventory (Beck \& Steer, 1984). A lower score is the desired outcome.
次要结局
- Gut microbiota changes(4 weeks)
研究者
Katherin Cohen-Kadosh
Principal Investigator
University of Surrey