Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-02-26 @ 4:16 PM
Study NCT ID:
NCT02618005
Status:
COMPLETED
Last Update Posted:
2025-11-25
First Post:
2015-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Probiotics on Immune Function and Intestinal Microbiota in Astronauts Under Closed Microgravity Environment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2022-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2015-11-01', 'studyFirstSubmitQcDate': '2015-11-25', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Longitudinal changes in the number of LcS in feces', 'timeFrame': '9-18 months', 'description': 'Number of LcS in feces will be assessed by PMA-qPCR, during pre-flight, in-flight and post-flight.'}, {'measure': 'Longitudinal changes in the level of immune markers', 'timeFrame': '9-18 months', 'description': 'Levels of immune markers in blood/saliva will be assessed by ELISA and bioassay, during pre-flight, in-flight and post-flight.'}, {'measure': 'Longitudinal changes in numbers and composition of intestinal microbiota', 'timeFrame': '9-18 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Astronauts', 'Probiotics', 'Immune function', 'Intestinal microbiota'], 'conditions': ['Immune Function and Intestinal Microbiota']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals who are scheduled to stay on the ISS for at least 3 months\n* Individuals who fully understand the study protocol and provide written informed consent for the study participation\n\nExclusion Criteria:\n\n* Individuals who routinely use antibiotic, laxative, and/or bowel regulating medicine\n* 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'}, 'identificationModule': {'nctId': 'NCT02618005', 'briefTitle': 'Probiotics on Immune Function and Intestinal Microbiota in Astronauts Under Closed Microgravity Environment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Yakult Honsha Co., LTD'}, 'officialTitle': 'Study for Evaluating the Impact of Continuous Consumption of Probiotics on Immune Function and Intestinal Microbiota in Astronauts Under Closed Microgravity Environment', 'orgStudyIdInfo': {'id': 'Probiotics'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LcS group', 'description': 'Consuming probiotic capsule', 'interventionNames': ['Dietary Supplement: Probiotic capsule']}, {'type': 'NO_INTERVENTION', 'label': 'Control group'}], 'interventions': [{'name': 'Probiotic capsule', 'type': 'DIETARY_SUPPLEMENT', 'description': '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)', 'armGroupLabels': ['LcS group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ibaraki', 'country': 'Japan', 'facility': 'Japan Aerospace Exploration Agency', 'geoPoint': {'lat': 34.81641, 'lon': 135.56828}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yakult Honsha Co., LTD', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Japan Aerospace Exploration Agency', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}