Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2026-05-04 @ 9:53 AM
Study NCT ID:
NCT02485405
Status:
COMPLETED
Last Update Posted:
2017-09-07
First Post:
2015-06-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gut Permeability and Stress
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011581', 'term': 'Psychological Tests'}], 'ancestors': [{'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Saliva Plasma/Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-06', 'studyFirstSubmitDate': '2015-06-23', 'studyFirstSubmitQcDate': '2015-06-25', 'lastUpdatePostDateStruct': {'date': '2017-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'gut permeability (marker measured in plasma/serum) in healthy young men participating in Trier social stress test', 'timeFrame': 'Volunteers will be followed by one hour after Trier social stress test'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stress']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to analyse gut permeability and stress.', 'detailedDescription': 'Healthy male volunteers (aged 19-35 years) participate in Trier social stress test while saliva and blood samples are withdrawn.\n\nSaliva will be used for analysis of cortisol and blood will be used for analysis of various biomarkers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy men aged 19-35 years old', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Man, 19-35 years old\n* Healthy\n\nExclusion Criteria:\n\n* Psychological disorders\n* Use of antibiotics or other drugs'}, 'identificationModule': {'nctId': 'NCT02485405', 'acronym': 'SP15', 'briefTitle': 'Gut Permeability and Stress', 'organization': {'class': 'OTHER', 'fullName': 'Lund University'}, 'officialTitle': 'Gut Permeability in Volunteers Participating in a Stress Test', 'orgStudyIdInfo': {'id': 'SP15_CarolineLinninge'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'stressed', 'description': 'stressed volunteers perform Trier social stress test', 'interventionNames': ['Other: Trier social stress test']}, {'label': 'non-stressed', 'description': 'non-stressed volunteers perform Trier social stress test', 'interventionNames': ['Other: Trier social stress test']}], 'interventions': [{'name': 'Trier social stress test', 'type': 'OTHER', 'description': 'Volunteers perform Trier social stress test', 'armGroupLabels': ['non-stressed', 'stressed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '221 00', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Lund University', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'overallOfficials': [{'name': 'Caroline Linninge, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lund University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lund University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Caroline Linninge', 'investigatorAffiliation': 'Lund University'}}}}