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

Summary

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.

Conditions

• Confinement and Isolation

Interventions

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.

DIETARY_SUPPLEMENT

placebo sachet containing maltodextrin and magnesium stearate.

placebo sachet containing maltodextrin and magnesium stearate.

Sponsors & Collaborators

• Dr. Isabelle Mack, Co-PI, University Hospital Tübigen

  collaborator UNKNOWN

• Dr. Claude Lambert, University Hospital of Saint-Etienne

  collaborator UNKNOWN

• Dr. John Penders, Maastricht University Medical Center

  collaborator UNKNOWN

• Dr. Joël Doré, Institut National de la Recherche Agronomique

  collaborator UNKNOWN

• European Space Agency

  collaborator OTHER

• University Hospital Tuebingen

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-11-15

Primary Completion

2022-07-01

Completion

2024-12-31

Countries

• Antarctica