Confinement and Isolation clinical trials

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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NCT ID: NCT03746145 Recruiting - Clinical trials for Confinement and Isolation

A Counter Measure for the Effects of Immune and Microbiome Changes in Environments With Limited ANtigen Diversity (ICELAND-TWO)

ICELAND-2

Start date: November 15, 2018
Phase: N/A
Study type: Interventional

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: 1. evaluates the effect of the probiotic BL1714 on well-being regarding mood, social integration and stress and other parameters . 2. determines the effect of an antigen-limited environment like Concordia on gut microbiota, immune system and epigenetics. 3. examines the interaction between the factors mentioned in 1. 4. examines the role of nutrition intake and behaviour in the interplay mentioned above.