Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2026-02-28 @ 2:04 PM
Study NCT ID:
NCT05836168
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-17
First Post:
2023-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Microbiome Modulation on Sleep in Working People
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'placebo, outcome assessors are blinded to the group allocation'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, placebo controlled study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-13', 'studyFirstSubmitDate': '2023-04-18', 'studyFirstSubmitQcDate': '2023-04-18', 'lastUpdatePostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Microbiome composition', 'timeFrame': '4 weeks', 'description': '16s rDNA analysis, beta diversity'}, {'measure': 'Metabolite composition', 'timeFrame': '4 weeks', 'description': 'NMR metabolomics'}, {'measure': 'Hair Cortisol levels', 'timeFrame': '4 weeks', 'description': 'Hair cortisol'}], 'primaryOutcomes': [{'measure': 'Change in subjective sleep quality', 'timeFrame': '4 weeks', 'description': 'Pittsburgh Sleep Quality Index (PSQI)'}], 'secondaryOutcomes': [{'measure': 'sleep latency', 'timeFrame': '4 weeks', 'description': 'Pittsburgh Sleep Quality Index (PSQI)'}, {'measure': 'sleep duration', 'timeFrame': '4 weeks', 'description': 'Pittsburgh Sleep Quality Index (PSQI)'}, {'measure': 'habitual sleep efficiency', 'timeFrame': '4 weeks', 'description': 'Pittsburgh Sleep Quality Index (PSQI)'}, {'measure': 'sleep disturbances', 'timeFrame': '4 weeks', 'description': 'Pittsburgh Sleep Quality Index (PSQI)'}, {'measure': 'use of sleeping medication', 'timeFrame': '4 weeks', 'description': 'Pittsburgh Sleep Quality Index (PSQI)'}, {'measure': 'daytime dysfunction', 'timeFrame': '4 weeks', 'description': 'Pittsburgh Sleep Quality Index (PSQI)'}, {'measure': 'Quality of life', 'timeFrame': '4 weeks', 'description': 'short form 12 (SF-12)'}, {'measure': 'perceived stress levels', 'timeFrame': '4 weeks', 'description': 'measured by perceived stress questionnaire (PSQ-20)'}, {'measure': 'Gastrointestinal quality of life', 'timeFrame': '4 weeks', 'description': 'measured by gastrointestinal quality of life index (GIQLI)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep']}, 'descriptionModule': {'briefSummary': 'We aim to test whether quality of sleep in working people can be improved by modulating the gut microbiome with probiotics.', 'detailedDescription': 'A good night´s sleep is essential for our attention, cognition and mood. Sleep fragmentation can therefore lead to poor performance, loss of productivity, and errors, incidents and accidents in the workplace. Sleep disruption has further been associated with metabolic and cardiovascular diseases, psychiatric diseases and cancer.The gut microbiome and its metabolites exhibit diurnal rhythmicity in response to food intake and influence human clock gene expression and sleep duration. Sleep fragmentation causes dysbiosis and hormonal disturbances. First data from animal experiments and small human studies imply that modulation of the gut microbiome may improve sleep quality and thereby mental and physical health. Probiotics can alter the gut microbiota composition and can mitigate positive effects on psychiatric symptoms via the microbiome gut-brain axis by metabolites such as short-chain fatty acids (SCFA) that can pass the blood-brain barrier and thereby comprise a potential strategy to improve sleep quality and other quality of life related outcomes. Evidence on the effect of probiotics to improve quality of sleep is available from several small-scale clinical studies in different populations. The benefit seems to be stronger in people under physical or mental stress.\n\nAlso, a large marketing survey conducted in Germany in over \\>10.000 consumers indicated that a multispecies probiotic, that has been described to improve inflammation, gut barrier dysfunction and immune function in different patient cohorts is able to improve sleep quality and quality of life, however since this study was non-randomized, a bias cannot be excluded.\n\nUnderstanding the interaction between the gut microbiome, chronobiology and health is therefore of high importance and in line with the United Nations\' Sustainable Development Goal 3 of the 2030 Agenda for Sustainable Development to "ensure healthy lives and promoting well-being for all at all ages".'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria\n\n* Age \\>18\n* Working\n* Signed Informed Consent;\n* Willing to accept use of all encoded data, including publication, and the confidential use and storage of all data for at least 15 years\n* Pittsburgh Sleep Quality index score of \\>5 Exclusion criteria\n* Diagnosed with a gastrointestinal infection within 4 weeks prior to screening\n* Severe gastrointestinal diseases (e.g. inflammatory bowel diseases)\n* Received any of the following products/medication within 4 weeks prior to screening: systemic antibiotics, prokinetics, prebiotic supplements, probiotic supplements\n* Concomitant diseases or other circumstances that suggest that the patients are not eligible for participation in the study'}, 'identificationModule': {'nctId': 'NCT05836168', 'acronym': 'Sleep', 'briefTitle': 'Effects of Microbiome Modulation on Sleep in Working People', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Effects of Microbiome Modulation on Sleep in Working People: A Randomized Controlled Pilot Trial', 'orgStudyIdInfo': {'id': '35-176 ex 22/23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Probiotic', 'description': 'multi-strain probiotic mixture containing Bifidobacterium bifidum W23, Bifidobacterium lactis W51, Bifidobacterium lactis W52, Lactobacillus acidophilus W22, Lactobacillus casei W56, Lactobacillus paracasei W20, Lactobacillus plantarum W62, Lactobacillus salivarius W24, Lactococcus lactis W19 in a matrix of maize starch, maltodextrin, inulin, potassium chloride, rice protein, magnesium sulfate, fructooligosaccharides, amylases and mangane sulfate at a dose of 2 x 3g per day for 4 weeks.', 'interventionNames': ['Dietary Supplement: Omnibiotic Stress Repair']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '2 x 3g of a similar looking and tasting placebo per day for 4 weeks.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Omnibiotic Stress Repair', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Omnibiotic Stress'], 'description': 'multispecies probiotic', 'armGroupLabels': ['Probiotic']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Graz', 'country': 'Austria', 'facility': 'Medical University Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Depending on the results, according to the grant contract, IPR will be shared among partners and after these discussions IPD may be shared. Microbiome sequencing data will be deposited in a public repository'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'collaborators': [{'name': 'CBmed Ges.m.b.H.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Univ. Prof. PD Dr. med', 'investigatorFullName': 'Vanessa Stadlbauer-Koellner, MD', 'investigatorAffiliation': 'Medical University of Graz'}}}}