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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
Sponsor:
Collaborators:
Dr. Isabelle Mack, Co-PI, University Hospital Tübigen
Dr. Claude Lambert, University Hospital of Saint-Etienne
Dr. John Penders, Maastricht University Medical Center
Dr. Joël Doré, Institut National de la Recherche Agronomique
European Space Agency
Information provided by (Responsible Party):
Prof. Dr. Paul Enck, University Hospital Tuebingen

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. 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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Experimental: Placebo
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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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

  8. 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

  9. 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

  10. POMS [ Time Frame: 1 day Predeparture, Antarctica winterover of 12 months ]
    Profile of mood states (POMS) questionnaire

  11. PANAS [ Time Frame: 1 day Predeparture, Antarctica winterover of 12 months ]
    Positive & negative affect schedule



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Crew members of the Concordia station in Antarctica

Exclusion Criteria:

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


Information from the National Library of Medicine

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


Contacts
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Contact: Isabelle Mack, Dr. +4970712985614 isabelle.mack@uni-tuebingen.de
Contact: Paul Enck, Prof. paul.enck@uni-tuebingen.de

Locations
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Antarctica
Concordia Station Recruiting
Concordia, Antarctica
Contact: Isabelle Mack, Dr.       isabelle.mack@uni-tuebingen.de   
Sponsors and Collaborators
University Hospital Tuebingen
Dr. Isabelle Mack, Co-PI, University Hospital Tübigen
Dr. Claude Lambert, University Hospital of Saint-Etienne
Dr. John Penders, Maastricht University Medical Center
Dr. Joël Doré, Institut National de la Recherche Agronomique
European Space Agency

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Responsible Party: Prof. Dr. Paul Enck, Director of Research, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT03746145     History of Changes
Other Study ID Numbers: ICELAND-2
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. Dr. Paul Enck, University Hospital Tuebingen:
probiotics
microbiota
gastrointestinal
immune system
immunology
stress
Bifidobacterium
hypoxia
confinement
isolation

Additional relevant MeSH terms:
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Sulfalene
Anti-Infective Agents
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents