Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-03-06 @ 6:38 PM
Study NCT ID:
NCT02974894
Status:
COMPLETED
Last Update Posted:
2016-12-01
First Post:
2016-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Lactobacillus Plantarum on Cortisol, IgA and Alpha-amylase Levels in Human Saliva During Stress
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015775', 'term': 'Fractures, Stress'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, '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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-30', 'studyFirstSubmitDate': '2016-11-21', 'studyFirstSubmitQcDate': '2016-11-23', 'lastUpdatePostDateStruct': {'date': '2016-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The impact of Lactobacillus plantarum on the levels of stress-induced cortisol in saliva.', 'timeFrame': 'Change from baseline in cortisol levels at 14 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stress Reaction']}, 'referencesModule': {'references': [{'pmid': '28101105', 'type': 'DERIVED', 'citation': 'Andersson H, Tullberg C, Ahrne S, Hamberg K, Lazou Ahren I, Molin G, Sonesson M, Hakansson A. Oral Administration of Lactobacillus plantarum 299v Reduces Cortisol Levels in Human Saliva during Examination Induced Stress: A Randomized, Double-Blind Controlled Trial. Int J Microbiol. 2016;2016:8469018. doi: 10.1155/2016/8469018. Epub 2016 Dec 22.'}]}, 'descriptionModule': {'briefSummary': 'In the present study the main goal has been to clarify the effect of the probiotic bacteria Lactobacillus plantarum 299v on the salivary cortisol level in young adults under examination stress. Salivary IgA from minor glands and in whole human saliva was measured as alternative marker of stress. The hypothesis was that the levels of cortisol would be reduced or stabilized in the test group in comparison to the placebo group where the cortisol levels were expected to increase due to the examination-induced stress. By contrast, the salivary IgA levels were expected to increase in the test group in comparison to the placebo group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults\n* studying at the University in Lund\n* participation in ongoing examination period\n\nExclusion Criteria:\n\n* pregnancy\n* intake of antibiotics\n* medication with cortisone during the study period'}, 'identificationModule': {'nctId': 'NCT02974894', 'briefTitle': 'The Effects of Lactobacillus Plantarum on Cortisol, IgA and Alpha-amylase Levels in Human Saliva During Stress', 'organization': {'class': 'OTHER', 'fullName': 'Lund University'}, 'officialTitle': 'The Effects of Lactobacillus Plantarum on Cortisol, IgA and Alpha-amylase Levels in Human Saliva During Stress', 'orgStudyIdInfo': {'id': 'Exjobb stress'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotic', 'description': 'Capsules containing potato starch as a filler and Lactobacillus plantarum', 'interventionNames': ['Dietary Supplement: Probiotic (Lactobacillus Plantarum)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Capsules containing potato starch', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Probiotic (Lactobacillus Plantarum)', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Probiotic']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Placebo']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lund University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}