Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2026-05-30 @ 3:35 PM
Study NCT ID:
NCT03080818
Status:
COMPLETED
Last Update Posted:
2020-02-20
First Post:
2017-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Probiotic on Psychological and Cognitive Effects
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']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-19', 'studyFirstSubmitDate': '2017-03-05', 'studyFirstSubmitQcDate': '2017-03-09', 'lastUpdatePostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in score on Center for Epidemiologic Studies Depression - R (CES-D-R)', 'timeFrame': 'Baseline and 12 week follow up', 'description': 'Depressive symptoms'}, {'measure': 'Change in score on State-Trait Anxiety Inventory', 'timeFrame': 'Baseline and 12 week follow up', 'description': 'Anxiety symptoms'}, {'measure': 'Change in score on Perceived Stress Scale', 'timeFrame': 'Baseline and 12 week follow up', 'description': 'Subjective stress'}, {'measure': 'Change in score on Positive and Negative Affect Schedule', 'timeFrame': 'Baseline and 12 week follow up', 'description': 'Fluctuations in affect'}, {'measure': 'Change in score on Profile of Mood States', 'timeFrame': 'Baseline and 12 week follow up', 'description': 'Fluctuations in affect - acute'}, {'measure': 'Change in score on Warwick-Edinburgh Mental Well-Being Scale', 'timeFrame': 'Baseline and 12 week follow up', 'description': 'Subjective wellbeing'}, {'measure': 'Change in score on OECD Life Satisfaction scale (short)', 'timeFrame': 'Baseline and 12 week follow up', 'description': 'Subjective wellbeing - general'}, {'measure': 'Change in score on Response to Stressful Events Scale', 'timeFrame': 'Baseline and 12 week follow up', 'description': 'Emotion regulation'}, {'measure': 'Change in score on Connor-Davidson Resilience Scale', 'timeFrame': 'Baseline and 12 week follow up', 'description': 'Emotional resilience'}], 'secondaryOutcomes': [{'measure': 'Change in Picture Sequence Memory Test and Auditory Verbal Learning Test scores', 'timeFrame': 'Baseline and 12 week follow up', 'description': 'Memory'}, {'measure': 'Change in Dimension Card Sort Test, Flanker Inhibitory Control, and List Sorting Working Memory Test scores', 'timeFrame': 'Baseline and 12 week follow up', 'description': 'Executive function/Attention'}, {'measure': 'Change in Pattern Comparison Processing Speed Test scores', 'timeFrame': 'Baseline and 12 week follow up', 'description': 'Processing Speed'}, {'measure': 'Change in SF-36 scores', 'timeFrame': 'Baseline and 12 week follow up', 'description': 'Quality of Life'}, {'measure': 'Change in Pittsburgh Sleep Quality Index scores', 'timeFrame': 'Baseline and 12 week follow up', 'description': 'Sleep patterns'}, {'measure': 'Change in Gastrointestinal Symptom Rating Scale scores', 'timeFrame': 'Baseline and 12 week follow up', 'description': 'Subjective gastrointestinal symptoms'}, {'measure': 'Change in HbA1c and fasting glucose values', 'timeFrame': 'Baseline and 12 week follow up', 'description': 'Laboratory measures of glycemic control'}, {'measure': 'Change in C-reactive protein, Interleukin-6, and TNF-alpha values', 'timeFrame': 'Baseline and 12 week follow up', 'description': 'Laboratory measures of inflammation'}, {'measure': 'Change in Total Cholesterol, HDL, LDL, and VLDL values', 'timeFrame': 'Baseline and 12 week follow up', 'description': 'Laboratory meausres of lipid levels'}, {'measure': 'Change in waking cortisol levels', 'timeFrame': 'Baseline and 12 week follow up', 'description': 'Laboratory measure of cortisol'}, {'measure': 'Change in composition of the gut microbiome', 'timeFrame': 'Baseline and 12 week follow up', 'description': 'Laboratory measure of gut microbiome'}, {'measure': 'Change in oral microbiome composition', 'timeFrame': 'Baseline and 12 week follow up', 'description': 'Laboratory measure of oral microbiome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Probiotic, Cognitive Function, Mood'], 'conditions': ['Aging']}, 'referencesModule': {'references': [{'pmid': '36228569', 'type': 'DERIVED', 'citation': 'Aljumaah MR, Bhatia U, Roach J, Gunstad J, Azcarate Peril MA. The gut microbiome, mild cognitive impairment, and probiotics: A randomized clinical trial in middle-aged and older adults. Clin Nutr. 2022 Nov;41(11):2565-2576. doi: 10.1016/j.clnu.2022.09.012. Epub 2022 Sep 28.'}, {'pmid': '35617704', 'type': 'DERIVED', 'citation': 'Sanborn V, Aljumaah M, Azcarate-Peril MA, Gunstad J. Examining the cognitive benefits of probiotic supplementation in physically active older adults: A randomized clinical trial. Appl Physiol Nutr Metab. 2022 Aug 1;47(8):871-882. doi: 10.1139/apnm-2021-0557. Epub 2022 May 26.'}]}, 'descriptionModule': {'briefSummary': 'This study will determine whether supplementation of probiotic Lactobacillus Rhamnosus GG improves psychological status in middle age and older adults through a 12-week, randomized, double-blind, placebo-controlled clinical trial. Secondary analyses will be conducted to examine the possible benefits of probiotic supplementation on cognitive function and markers of physical health.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 55-75 years\n* Able to speak and read English\n\nExclusion Criteria:\n\n* History of neurological, developmental, or severe psychiatric disorder (e.g. dementia, stroke, schizophrenia);\n* Antibiotic use in the past 30 days;\n* History of significant stomach or GI surgery (e.g. gastric bypass, cholecystectomy);\n* History of alcohol or illicit drug dependence;\n* History of severe heart, kidney, or liver problems (e.g. heart failure, liver failure);\n* Regular use of an acid-blocking medication in the past 30 days (i.e. proton pump inhibitor, H2 blocker);\n* Likely immunosuppression (e.g. chemotherapy treatment);\n* Regular use of other pre- or probiotic supplements in the past 30 days;\n* Severe gastrointestinal conditions including celiac disease, Crohn's disease, or diverticulitis."}, 'identificationModule': {'nctId': 'NCT03080818', 'briefTitle': 'Probiotic on Psychological and Cognitive Effects', 'organization': {'class': 'OTHER', 'fullName': 'Kent State University'}, 'officialTitle': 'Evaluation of a Probiotic on Psychological and Cognitive Effects in Middle and Older Adults', 'orgStudyIdInfo': {'id': 'Kent State University'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotic', 'description': 'Participants in this arm will receive probiotic supplementation for 12 weeks (Lactobacillus Rhamnosus GG)', 'interventionNames': ['Dietary Supplement: Probiotic - Lactobacillus Rhamnosus GG']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Participants in this arm will receive placebo that look similar to probiotics', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Probiotic - Lactobacillus Rhamnosus GG', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 capsules per day for 90 days', 'armGroupLabels': ['Probiotic']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '2 placebo capsules per day for 90 days', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44242', 'city': 'Kent', 'state': 'Ohio', 'country': 'United States', 'facility': 'Kent State Uniersity', 'geoPoint': {'lat': 41.15367, 'lon': -81.35789}}], 'overallOfficials': [{'name': 'John Gunstad, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kent State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kent State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'iHealth', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'John Gunstad', 'investigatorAffiliation': 'Kent State University'}}}}