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

Immune Function and Intestinal Microbiota Clinical Trial

Official title:

Study for Evaluating the Impact of Continuous Consumption of Probiotics on Immune Function and Intestinal Microbiota in Astronauts Under Closed Microgravity Environment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02618005
• Other study ID #: Probiotics
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2015
• Est. completion date: March 2023

Study information

• Verified date: August 2021
• Source: Yakult Honsha Co., LTD
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Human immune function and intestinal microbiota are suggested to be altered within long-duration stay in space. Accumulated evidences on earth support that Lactobacillus casei 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Immune Function and Intestinal Microbiota

Intervention

Dietary Supplement:
• 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)

Locations

Country	Name	City	State
Japan	Japan Aerospace Exploration Agency	Ibaraki

Sponsors (2)

Lead Sponsor	Collaborator
Yakult Honsha Co., LTD	Japan Aerospace Exploration Agency

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Longitudinal changes in the number of LcS in feces	Number of LcS in feces will be assessed by PMA-qPCR, during pre-flight, in-flight and post-flight.	9-18 months
Primary	Longitudinal changes in the level of immune markers	Levels of immune markers in blood/saliva will be assessed by ELISA and bioassay, during pre-flight, in-flight and post-flight.	9-18 months
Primary	Longitudinal changes in numbers and composition of intestinal microbiota	Numbers and composition of bacteria in feces will be assessed by RT-qPCR/qPCR and next generation sequencer analysis, during pre-flight, in-flight and post-flight.	9-18 months