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

NCT03746145 | Unknown

• 1 other identifier: ICELAND-2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Confinement and Isolation

Keywords

probiotics; microbiota; gastrointestinal; immune system; immunology; stress; Bifidobacterium; hypoxia; confinement; isolation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• 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

Study Arms (2)

Bifidobacterium longum 1714

EXPERIMENTAL

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

Placebo

EXPERIMENTAL

Participants consume one 2g placebo sachet containing maltodextrin and magnesium stearate.

Dietary Supplement: placebo sachet containing maltodextrin and magnesium stearate.

Interventions

Bifidobacterium longum 1714 DIETARY_SUPPLEMENT

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.

Bifidobacterium longum 1714

placebo sachet containing maltodextrin and magnesium stearate. DIETARY_SUPPLEMENT

placebo sachet containing maltodextrin and magnesium stearate.

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Crew members of the Concordia station in Antarctica

You may not qualify if:

• Participants which are not crew members of the Concordia station in Antarctica

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• Dr. Isabelle Mack, Co-PI, University Hospital Tübigen: collaborator
• Dr. Claude Lambert, University Hospital of Saint-Etienne: collaborator
• Dr. John Penders, Maastricht University Medical Center: collaborator
• Dr. Joël Doré, Institut National de la Recherche Agronomique: collaborator
• European Space Agency: collaborator

Study Sites (1)

Concordia Station

Concordia, Antarctica

RECRUITING

MeSH Terms

Conditions

Hypoxia

Interventions

stearic acid

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Isabelle Mack, Dr.

CONTACT

+4970712985614; isabelle.mack@uni-tuebingen.de

Paul Enck, Prof.

CONTACT

paul.enck@uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Model Details: 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.

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 19, 2018
• Study Start: November 15, 2018
• Primary Completion: July 1, 2022
• Study Completion: December 31, 2024
• Last Updated: November 19, 2018

Record last verified: 2018-11

Locations

AN (1)