Effect of Probiotics on Central Nervous System Functions in Humans
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Neural response to social stress measured by Magnetoencephalography
研究概览
简要总结
The gut-brain axis is described as being important in both, gut functions and central nervous system (CNS) functions. The microbiota in the gut plays an important role in this axis through neural, immune and endocrine systems. Previous studies have found altered gut microbiota (GM) composition could change the CNS functions in animals and humans. Probiotics were shown having positive effect on improving stress response in animals and stress related psychiatry in humans. The current study will investigate if probiotics can improve response to social stress in healthy participants and patients with irritable bowel syndrome (IBS), which is a stress-related disease, and whether this probiotic action can be counteracted by the locally acting antibiotic, Rifaximin. The investigators will use the Cyberball paradigram to induce social stress and magnetoencephalography (MEG) to record neural responses related to the social stress. The administration of the probiotics will be a new strategy for both the mental health management and treatment of gastrointestinal (GI) disorders in the future.
详细描述
Understanding the neural mechanisms underlying the experience of social stress may help to prevent the development of IBS and to help people to maintain their mental health. Social distress has been examined with the Cyberball paradigm in developing peers and children with autism spectrum disorders, people with social anxiety disorder and with borderline personality disorder. These studies provided researchers the clinical evidence and validity of the paradigm in patients . Here the investigators will examine the neural response of healthy volunteers to acute stress induced by the Cyberball game and if acute intervention with probiotics for 4 weeks can alleviate the stress response. The study will be firstly conducted on healthy volunteers whose GM will be disturbed by an antibiotic Rifaximin as to simulate IBS patients, to see their neural response to the social exclusion (Study 1). The second study will be conducted as a clinical trial in healthy volunteers to investigate the effect of the probiotic Bifidobacterium longum 1714 (Study 2).
Study 1 & 2 will be a randomized, double blind, double dummy design, during which the participants will visit the laboratory for 2 times (M1, M2,): measurement at baseline and after intervention. Intervention period lasts for 1 week in study 1 and 4 weeks in study 2.
In study 1, Group 1 will take Rifaximin for 1 week Group 2 will take Placebo for 1 week
In study 2, Group 1 will take B.longum 1714 for 4 weeks Group 2 will take Placebo for for 4 weeks
Participants will be not allowed to eat certain kinds of food. As mentioned in the exclusion criteria, participants will not eat probiotic/prebiotic containing food supplements, or potentially immune-enhancing dietary supplements either. The food to be avoided will be summarized on a list of probiotic/prebiotic containing food. Also, participants will be asked to record the food they take on each day during the intervention, by taking photos. Nutritional information about the food taken by the participants will be analyzed by using an online tool http://nutritiondata.self.com/.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female volunteers aged 18 to 50 years.
- •Signed informed consent. Written informed consent will need to be obtained from all participants, and the protocol will be submitted to the Ethics Board of the Medical School for approval,
- •Participant is willing to comply with the study restrictions.
- •Participant has been a non-smoker for at least 3 months.
- •Participants with body mass index 18-30.
排除标准
- •Participants are current smokers,
- •Participants have chronic allergies,
- •Participants are unwilling to discontinue the consumption of probiotic- and prebiotic-containing foods or potentially immune-enhancing dietary supplements (i.e. prebiotics, probiotics, Echinacea, fish oil and vitamin E (>400 % of the RDA or .60 mg/d)),
- •Participants received an immune-suppressing intervention or have an immunosuppressive illness within the last year,
- •Participants have a psychiatric disorder (eg. depression, anxiety, dysthymia, panic disorder, disorder of mania or bipolar disorder, phobia, post-traumatic stress disorder, substance abuse, eating disorder) (only for recruiting healthy volunteers).
- •Participants received antibiotic therapy within the last 2 months of their study start date.
- •Participants have non-removable metal parts in the body such as: pacemaker, artificial heart valves, metal prostheses, implanted magnetic metal parts (screws), spiral, metal fragments / shrapnel, fixed braces, acupuncture needle, insulin pump, tattoos, eye shadow. Also, people with agoraphobia will be excluded.
- •Patients who do not meet the diagnosis criteria of IBS based on Rome I, II, or III (only for recruiting patients).
研究组 & 干预措施
Active (rifaximin/B.longum 1714)
干预措施: Probiotic (Dietary Supplement)
Active (rifaximin/B.longum 1714)
干预措施: Antibiotic (Drug)
Placebo
干预措施: Placebo for antibiotic (Dietary Supplement)
Placebo
干预措施: Placebo for probiotic (Dietary Supplement)
结局指标
主要结局
Neural response to social stress measured by Magnetoencephalography
时间窗: 8 weeks
次要结局
- Bacterial population levels in faecal samples(8 weeks)
- Cortisol levels in blood samples(8 weeks)
- Tryptophan levels in blood samples(8 weeks)
- Score of the Hospital Anxiety and Depression Scale (HADS)(8 weeks)
- Scores of the Positive and Negative Affect Scales (PANAS)(8 weeks)
- Scores of the RAND 36-Item Healthy Survey(8 weeks)