A Counter Measure for the Effects of Immune and Microbiome Changes in Environments With Limited ANtigen Diversity (ICELAND-TWO) (ICELAND-2)
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|ClinicalTrials.gov Identifier: NCT03746145|
Recruitment Status : Recruiting
First Posted : November 19, 2018
Last Update Posted : November 19, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Confinement and Isolation||Dietary Supplement: Bifidobacterium longum 1714 Dietary Supplement: placebo sachet containing maltodextrin and magnesium stearate.||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||During the entire winter over (WO) period, from arrival at COCORDIA until departure (1 year), participants receive 2g nutritional supplement powder (sachet, containing 10e11 CFU Bifidobacterium longum 1714 or placebo) once every day, to be taken in the morning with breakfast throughout the year.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||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|
|Estimated Study Start Date :||November 15, 2018|
|Estimated Primary Completion Date :||July 1, 2022|
|Estimated Study Completion Date :||December 31, 2024|
Experimental: 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.
Dietary Supplement: Bifidobacterium longum 1714
This is a double-blind randomized placebo-controlled pilot study. Participants under extreme conditions of hypoxia, confinement and isolation receive Bifidobacterium longum 1714 on a daily basis over one year in order to test improvements on stress resilience and immune functions.
Participants consume one 2g placebo sachet containing maltodextrin and magnesium stearate.
Dietary Supplement: placebo sachet containing maltodextrin and magnesium stearate.
placebo sachet containing maltodextrin and magnesium stearate.
- Expert rating by medical doctor on well-being of participant [ Time Frame: 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)
- Participant rating on well-being [ Time Frame: measurement monthly over 12 months ]The participants will perform a self-rating of their well-being using the same visual analogue scales as the medical doctor for the primary outcome.
- Discrepancy between ratings on well-being [ Time Frame: measurement monthly over 12 months ]The discrepancy between the expert-rating and the self-rating will be calculated
- Gastrointestinal symptoms [ Time Frame: Measurements at 1 day predeparture, in Antarctica at months 4,9 and 12 and 6 months postdeparture ]Gastrointestinal symptoms will be assessed using the gastrointestinal symptom rating scale
- Gastrointestinal microbiota [ Time Frame: stool samples collected at 1 day predeparture, in Antarctica monthly over 1 year and 6 months postdeparture ]Gastrointestinal microbiota composition and diversity measures analysed from stool samples using 16S rRNA sequencing and shotgun sequencing
- Immune system [ Time Frame: Measurements at 1 day predeparture, in Antarctica at months 4,9 and 12 and 6 months postdeparture ]Cognate immune system analyzed from blood samples using FACS
- Epigenetics [ Time Frame: Measurements at 1 day predeparture, in Antarctica at months 4,9 and 12 and 6 months postdeparture ]Histone modification and DNA methylation with focus on immune biology (DNA from saliva samples) using state of the art techniques e.g. Chromatin immunoprecipitation (ChIP)-based methods and high-performance liquid chromatography (HPLC), bisulfite sequencing, and CpG island microarrays.
- Interaction between microbiota and immune biology (including epigenetics) [ Time Frame: 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) by using novel bioinformatic and statistic models e.g. distance based redundancy analysis
- Nutrition [ Time Frame: FFQ: Measurements at 1 day predeparture, in Antarctica at months 4,9 and 12 and 6 months postdeparture ]Influence of nutrition and nutritional habits on healths using Food Frequency Questionnaires (FFQ) and standardized photographies of meals
- Medical and psychological data records assessed by the medical doctors of the European Space Agency [ Time Frame: 1 day Predeparture, Antarctica winterover of 12 months ]Medical and psychological data records assessed by the medical doctors of the European Space Agency
- POMS [ Time Frame: 1 day Predeparture, Antarctica winterover of 12 months ]Profile of mood states (POMS) questionnaire
- PANAS [ Time Frame: 1 day Predeparture, Antarctica winterover of 12 months ]Positive & negative affect schedule
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03746145
|Contact: Isabelle Mack, Dr.||+email@example.com|
|Contact: Paul Enck, Prof.||firstname.lastname@example.org|
|Contact: Isabelle Mack, Dr. email@example.com|