A Counter Measure for the Effects of Immune and Microbiome Changes in Environments With Limited ANtigen Diversity (ICELAND-TWO) - a Randomized Double Blind Controlled Pilot Study With Bifidobacterium Longum 1714
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Expert rating by medical doctor on well-being of participant
研究概览
简要总结
There is evidence to indicate that the gut microbiota has an effect on mental well-being and stress behaviours. This is highly relevant to both life on earth and spaceflight missions, in which mental well-being is crucial to mission success. Bifidobacterium longum 1714 (BL 1714), will be tested in the project ICELAND-2 in a double-blind, randomized placebo-controlled pilot study in crew members of the Antarctica station CONCORDIA in order to test stress resilience and possible outcomes on the immune system since the metabolic stress response and the immune system are closely interrelated. Crew members of CONCORDIA station have a prolonged stay (roughly 12 months) in a confined (antigen exposure restricted, overclean) and isolated environment, mimicking the situation of long-term space travel. ICELAND-2 will be conducted over three consecutive winter-over periods (3 years).
The project ICELAND-2:
- evaluates the effect of the probiotic BL1714 on well-being regarding mood, social integration and stress and other parameters .
- determines the effect of an antigen-limited environment like Concordia on gut microbiota, immune system and epigenetics.
- examines the interaction between the factors mentioned in 1.
- examines the role of nutrition intake and behaviour in the interplay mentioned above.
详细描述
EXPERIMENT CONCEPT
This is a double-bind, controlled pilot study where volunteers will receive a novel nutritional supplement powder (sachet, containing 1011 CFU Bifidobacterium longum 1714 (Alimentary 11 Health, Cork, Ireland) or placebo) once every day, to be taken in the morning with breakfastthroughout the year. The intervention starts for every participant at arrival (individual start). Using this study design, benefits of the probiotic on height adaptation can be also studied.
The experimental concept is based on the collection of biosamples (saliva, blood, stool) and some paper-pencil and documentary data only. Thereby, the interference of the project with the daily activities of the CONCORDIA crew is minimal. Both, female and male participants are included.
- One blood, one saliva and one stool sample prior to the CONCORDIA stay, in addition to paper-pencil data collection once at the same time (-2 to 3 months prior to the stay - T Zero, BDC)
- Three blood as well as a saliva samples (month 1, months 4 and 9, corresponding to T0, T4 and T9) during the CONCORDIA stay, as well as monthly collection of stool samples (months 1 to 9, T1 to T9), plus questionnaire data (paper-pencil data and/or online).
- One blood, one saliva and one stool sample after the CONCORDIA stay, in addition to paper-pencil data collection once at the same time (3 to 6 months after the stay - T12)
Saliva Sampling: a standard saliva sampling kit (Oragene-DNA - OG-500, DNA Genotec, Ottawa, ON, Canada) will be used (see Figure 2).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Crew members of the Concordia station in Antarctica
排除标准
- •Participants which are not crew members of the Concordia station in Antarctica
研究组 & 干预措施
Bifidobacterium longum 1714
Participants consume one 2g sachet containing 10e11 colony-forming units Bifidobacterium longum 1714 strain with maltodextrin and magnesium stearate on a daily basis over 1 year.
干预措施: Bifidobacterium longum 1714 (Dietary Supplement)
Placebo
Participants consume one 2g placebo sachet containing maltodextrin and magnesium stearate.
干预措施: placebo sachet containing maltodextrin and magnesium stearate. (Dietary Supplement)
结局指标
主要结局
Expert rating by medical doctor on well-being of participant
时间窗: up to 12 months
The medical doctors will rate the well-being of participants structured using 10 visual analogue scales monthly. The scales comprise the topics stress, stress coping, mood and physical health. This Rating is done ahead of the participant ratings (see sec. outcomes)
次要结局
- Participant rating on well-being(measurement monthly over 12 months)
- Discrepancy between ratings on well-being(measurement monthly over 12 months)
- Immune system(Measurements at 1 day predeparture, in Antarctica at months 4,9 and 12 and 6 months postdeparture)
- Epigenetics(Measurements at 1 day predeparture, in Antarctica at months 4,9 and 12 and 6 months postdeparture)
- Interaction between microbiota and immune biology (including epigenetics)(Measurements at 1 day predeparture, in Antarctica at months 4,9 and 12 and 6 months postdeparture)
- Nutrition(FFQ: Measurements at 1 day predeparture, in Antarctica at months 4,9 and 12 and 6 months postdeparture)
- PANAS(1 day Predeparture, Antarctica winterover of 12 months)
- Gastrointestinal symptoms(Measurements at 1 day predeparture, in Antarctica at months 4,9 and 12 and 6 months postdeparture)
- Gastrointestinal microbiota(stool samples collected at 1 day predeparture, in Antarctica monthly over 1 year and 6 months postdeparture)
- Medical and psychological data records assessed by the medical doctors of the European Space Agency(1 day Predeparture, Antarctica winterover of 12 months)
- POMS(1 day Predeparture, Antarctica winterover of 12 months)
研究者
Prof. Dr. Paul Enck
Director of Research
University Hospital Tuebingen