Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-03-08 @ 1:48 AM
Study NCT ID:
NCT03284905
Status:
COMPLETED
Last Update Posted:
2019-03-20
First Post:
2017-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Probiotic Intervention for Acute Stress
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-19', 'studyFirstSubmitDate': '2017-09-13', 'studyFirstSubmitQcDate': '2017-09-13', 'lastUpdatePostDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of the cortisol level during acute stress', 'timeFrame': '2.5 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stress']}, 'descriptionModule': {'briefSummary': 'Efficacy of probiotics on acute stress'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 19-35 years\n* SMBQ-score ≥3.75\n* Understand Swedish in spoken and written terms\n* Willing and able to give written informed consent for participating in the study\n* Intake of probiotics within two weeks prior to the start of the study\n\nExclusion Criteria:\n\n* BMI\\> 30\n* Pregnant\n* Antibiotic treatment in the last three months\n* Known disease (diabetes, pulmonary or cardiovascular disease, celiac disease, thyroid problems, gastrointestinal disease) or mental illness\n* Use of psychotropic drugs, beta blockers, asthma or rheumatoid arthritis drugs, steroid drugs or local steroid treatment'}, 'identificationModule': {'nctId': 'NCT03284905', 'briefTitle': 'Probiotic Intervention for Acute Stress', 'organization': {'class': 'INDUSTRY', 'fullName': 'Probi AB'}, 'officialTitle': 'Probiotic Intervention for Acute Stress', 'orgStudyIdInfo': {'id': 'SP17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Probiotics', 'interventionNames': ['Dietary Supplement: Probiotic supplement']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo supplement']}], 'interventions': [{'name': 'Probiotic supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Capsule containing freeze dried probiotic bacteria together with maize starch', 'armGroupLabels': ['Probiotics']}, {'name': 'Placebo supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Capsule containing maize starch', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '223 00', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Department of Food Technology, Engineering and Nutrition, Lund University', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Probi AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}