NCT03746145|Unknown
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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ICELAND-2
Sponsor study identifier
interventional
40
1 country
1
Study Start
November 15, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
July 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 8, 2018
Actual (reported)November 15, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 19, 2018
Actual (reported)July 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Expert rating by medical doctor on well-being of participant
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)
up to 12 months
Participant rating on well-being
measurement monthly over 12 months
Discrepancy between ratings on well-being
measurement monthly over 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
Immune system
Measurements at 1 day predeparture, in Antarctica at months 4,9 and 12 and 6 months postdeparture
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.
Participants consume one 2g placebo sachet containing maltodextrin and magnesium stearate.
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.
placebo sachet containing maltodextrin and magnesium stearate.
Concordia Station
Concordia Station, Antarctica
First Submitted
November 8, 2018
First Posted
November 19, 2018
Study Start
November 15, 2018
Estimated (date passed)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
July 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 19, 2018
Record last verified: 2018-11
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