Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2026-01-07 @ 6:17 AM
Study NCT ID:
NCT03160066
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2015-12-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Lactobacillus Rhamnosus (JB-1) on Stress and Cognition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-24', 'studyFirstSubmitDate': '2015-12-17', 'studyFirstSubmitQcDate': '2017-05-17', 'lastUpdatePostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Cognition', 'timeFrame': 'Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment', 'description': 'A battery of cognitive tests will be assessed using the Cambridge Neuropsychological Test Automated Battery'}], 'secondaryOutcomes': [{'measure': 'Change in the Inflammatory profile', 'timeFrame': 'Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment', 'description': 'Cytokine levels and toll-like receptor activity'}, {'measure': 'Changes in Mood', 'timeFrame': 'Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment', 'description': 'Beck Depression Inventory'}, {'measure': 'Change in Electroencephalography (EEG)', 'timeFrame': 'Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment', 'description': 'EEG measures of absolute power in the delta (1.5-3.5Hz), theta (4-7.5Hz), alpha1 (8- 9.5Hz), alpha2 (10-12.5Hz), beta1 (13-17.5Hz), and beta2 (18-25.5Hz) frequency bands'}, {'measure': 'Change in Salivary cortisol concentrations', 'timeFrame': 'Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment', 'description': 'Salivary cortisol will be collected before and after the socially evaluated cold pressor procedure.'}, {'measure': 'Changes in Anxiety', 'timeFrame': 'Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment', 'description': 'Beck Anxiety Inventory'}, {'measure': 'Changes in Stress levels', 'timeFrame': 'Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment', 'description': 'Perceived Stress Scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Psychobiotic', 'Brain-gut axis', 'Stress', 'Cognition', 'EEG'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Emerging evidence suggests that microorganisms acting via the Brain-Gut axis may have potential benefits for the management of stress-related conditions. The majority of studies have focused on animal models. Preclinical studies have identified the Lactobacillus Rhamnosus JB-1 strain as a putative psychobiotic with an impact on stress-related behaviours, physiology and cognitive performance. Whether such preclinical effects could be translated to healthy human volunteers remains unknown.', 'detailedDescription': '30 healthy male volunteers will be recruited in a randomized single blind placebo controlled cross over trial. Study participation will involve a screening visit followed by a baseline cognitive test battery, EEG and stress visit (socially evaluated cold-pressor test). These measures will be repeated after 4 weeks of daily probiotic and placebo capsules.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* able to give informed written consent\n* able to speak English\n\nExclusion Criteria:\n\n* having a significant acute or chronic illness\n* following a diet or taking a medication that would interfere with study objectives\n* pose a safety risk or confound the interpretation of the study results\n* evidence of immunodeficiency, bleeding disorder or coagulopathy\n* English not being participant's first language\n* colour blindness\n* dyslexia or dyscalculia\n* taking any probiotic products or antibiotics in the last 4 weeks\n* receiving any treatment involving experimental drugs"}, 'identificationModule': {'nctId': 'NCT03160066', 'briefTitle': 'The Effects of Lactobacillus Rhamnosus (JB-1) on Stress and Cognition', 'organization': {'class': 'OTHER', 'fullName': 'University College Cork'}, 'officialTitle': 'The Effects of Lactobacillus Rhamnosus (JB-1) on Stress and Cognition in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'APC057'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active', 'description': 'Capsules containing 1x10\\^9 colony forming units of Lactobacillus Rhamnosus (JB-1) will be given once per day for 4 weeks.', 'interventionNames': ['Dietary Supplement: Lactobacillus Rhamnosus (JB-1)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo capsules identical to the probiotic in taste, smell, colour, and comprised only of the same non-active ingredients (corn starch, magnesium stearate and silicon dioxide) in the probiotic supplement will be given once per day for 4 weeks.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Lactobacillus Rhamnosus (JB-1)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Lactobacillus Rhamnosus (JB-1) capsule', 'armGroupLabels': ['Active']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'Cork', 'city': 'Cork', 'country': 'Ireland', 'facility': 'APC Microbiome Institute', 'geoPoint': {'lat': 51.89797, 'lon': -8.47061}}], 'overallOfficials': [{'name': 'Ted Dinan, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University College Cork'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College Cork', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Prof Ted Dinan', 'investigatorAffiliation': 'University College Cork'}}}}