Probiotics on Immune Function and Intestinal Microbiota in Astronauts Under Closed Microgravity Environment

NCT ID: NCT02618005

Last Updated: 2025-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2022-04-30

Brief Summary

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Human immune function and intestinal microbiota are suggested to be altered within long-duration stay in space. Accumulated evidences on earth support that Lacticaseibacillus paracasei strain Shirota (LcS) is a promising probiotic strain on improvement of immune function and intestinal microbiota. This study aims to investigate the impact of long-duration spaceflight as well as intake of LcS on the international space station (ISS), on immune system and intestinal microbiota in astronauts.

Detailed Description

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Conditions

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Immune Function and Intestinal Microbiota

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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LcS group

Consuming probiotic capsule

Group Type EXPERIMENTAL

Probiotic capsule

Intervention Type DIETARY_SUPPLEMENT

Continuously take five capsules containing freeze-dried LcS on ISS for four weeks, from four weeks before the return (R-4W) to one day before the return (R-1d)

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Probiotic capsule

Continuously take five capsules containing freeze-dried LcS on ISS for four weeks, from four weeks before the return (R-4W) to one day before the return (R-1d)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Individuals who are scheduled to stay on the ISS for at least 3 months
* Individuals who fully understand the study protocol and provide written informed consent for the study participation

Exclusion Criteria

* Individuals who routinely use antibiotic, laxative, and/or bowel regulating medicine
* Individuals who participate in other research that competes with this study in terms of the purpose and field, e.g., study with dietary management or intake of bifidobacteria/lactic acid bacteria, oligosaccharides, antibiotic, laxative, and/or bowel regulating medicine
Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Japan Aerospace Exploration Agency

OTHER

Sponsor Role collaborator

Yakult Honsha Co., LTD

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Japan Aerospace Exploration Agency

Ibaraki, , Japan

Site Status

Countries

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Japan

Other Identifiers

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Probiotics

Identifier Type: -

Identifier Source: org_study_id

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