Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-02-27 @ 1:07 AM
Study NCT ID:
NCT02349360
Status:
COMPLETED
Last Update Posted:
2018-06-14
First Post:
2014-07-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Tolerability and Host Response to Lactobacillus Johnsonii
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C100843', 'term': 'Lacteol'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wdahl@ufl.edu', 'phone': '3522943707', 'title': 'Wendy Dahl Associate Professor', 'organization': 'University of Florida'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Probiotic', 'description': 'L. johnsonii N6.2 10\\^10 CFU in capsule form administered for 8 weeks\n\nL. johnsonii N6.2: L. johnsonii N6.2 10\\^10 CFU in capsule form administered for 8 weeks', 'otherNumAtRisk': 21, 'otherNumAffected': 1, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Encapsulated starch placebo administered for 8 weeks\n\nPlacebo: Encapsulated starch placebo administered for 8 weeks', 'otherNumAtRisk': 20, 'otherNumAffected': 2, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Sinus Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Fractured clavical', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Dental Abcess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Reporting Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Probiotic', 'description': 'L. johnsonii N6.2 10\\^10 CFU in capsule form administered for 8 weeks\n\nL. johnsonii N6.2: L. johnsonii N6.2 10\\^10 CFU in capsule form administered for 8 weeks ('}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Encapsulated starch placebo administered for 8 weeks\n\nPlacebo: Encapsulated starch placebo administered for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '13 weeks', 'description': 'The number of participants reporting Adverse Events was reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects completing the probiotic and the placebo intervention.'}, {'type': 'SECONDARY', 'title': 'Composite Measure of Blood Chemistry Profiles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Probiotic', 'description': 'L. johnsonii N6.2 10\\^10 CFU in capsule form administered for 8 weeks\n\nL. johnsonii N6.2: L. johnsonii N6.2 10\\^10 CFU in capsule form administered for 8 weeks ('}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Encapsulated starch placebo administered for 8 weeks\n\nPlacebo: Encapsulated starch placebo administered for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '13 weeks', 'description': 'Number of clinically relevant out of range values of the comprehensive metabolic panel and hemogram during intervention through washout period vs baseline.', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects completing intervention and final blood draw after 4 week washout period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Probiotic', 'description': 'L. johnsonii N6.2 in capsule form administered for 8 weeks\n\nL. johnsonii N6.2: L. johnsonii N6.2 in capsule form administered for 8 weeks'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Encapsulated starch placebo administered for 8 weeks\n\nPlacebo: Encapsulated starch placebo administered for 8 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Probiotic', 'description': 'L. johnsonii N6.2 10\\^10 CFU in capsule form administered for 8 weeks\n\nL. johnsonii N6.2: L. johnsonii N6.2 10\\^10 CFU in capsule form administered for 8 weeks'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Encapsulated starch placebo administered for 8 weeks\n\nPlacebo: Encapsulated starch placebo administered for 8 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '36'}, {'value': '21', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '48'}, {'value': '21', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '48'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-18', 'studyFirstSubmitDate': '2014-07-02', 'resultsFirstSubmitDate': '2017-12-21', 'studyFirstSubmitQcDate': '2015-01-27', 'lastUpdatePostDateStruct': {'date': '2018-06-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-04-19', 'studyFirstPostDateStruct': {'date': '2015-01-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Reporting Adverse Events', 'timeFrame': '13 weeks', 'description': 'The number of participants reporting Adverse Events was reported.'}], 'secondaryOutcomes': [{'measure': 'Composite Measure of Blood Chemistry Profiles', 'timeFrame': '13 weeks', 'description': 'Number of clinically relevant out of range values of the comprehensive metabolic panel and hemogram during intervention through washout period vs baseline.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['safety', 'tolerability'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '28659913', 'type': 'DERIVED', 'citation': 'Marcial GE, Ford AL, Haller MJ, Gezan SA, Harrison NA, Cai D, Meyer JL, Perry DJ, Atkinson MA, Wasserfall CH, Garrett T, Gonzalez CF, Brusko TM, Dahl WJ, Lorca GL. Lactobacillus johnsonii N6.2 Modulates the Host Immune Responses: A Double-Blind, Randomized Trial in Healthy Adults. Front Immunol. 2017 Jun 12;8:655. doi: 10.3389/fimmu.2017.00655. eCollection 2017.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/28659913', 'label': 'Lactobacillus johnsonii N6.2 Modulates the Host Immune Responses: A Double-Blind, Randomized Trial in Healthy Adults.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to determine the effects of the probiotic, Lactobacillus johnsonii N6.2, on safety, gastrointestinal function, wellness, fecal bacteria and blood biomarkers in healthy individuals.', 'detailedDescription': 'Healthy adult volunteers from 18-50 years of age will be recruited through the University of Florida and randomly distributed into two groups. This study is divided into 3 phases: baseline, intervention (study treatment) and washout. Participants will receive either the probiotic or placebo during the intervention phases. During the baseline phase, blood and fecal samples will be collected about 1 week before intervention initiation. On the day of a scheduled blood draw, the participant will need to arrive fasted overnight, and a light breakfast will be provided after blood draw. Starting on day 1 of the intervention phase, a second baseline blood sample will be collected and the participant will begin the study intervention (probiotic or placebo). Participants will consume 1 capsule (probiotic or placebo) daily for 8 weeks, and blood and stool samples will be collected and processed (on or around weeks 2, 4 and 8 of the intervention phase). A Fisher Scientific commode specimen collection system will be provided for stool collections. The stool collection kit may be taken home (participants will be asked to drop off the stool within 4 hours of defecation) for fecal sample collection or may use the restroom in the clinical lab at the Food Science and Human Nutrition Building in which kits will be provided for use. In the wash-out phase, participants will not consume the capsule (either the probiotic or placebo), but will provide blood and stool samples (on or around week 12). Throughout the study, participants will provide a total of 5 stool samples and 6 blood samples. Participants will be asked to complete daily and weekly questionnaires throughout all phases of the study, which will ask about quality of life (physical functioning, mental functioning, level of sleep, etc.), gastrointestinal function, and dietary intake. These assessments will be self-reported via online questionnaires. In the event that internet access is not available for a portion of the study, paper copies of the questionnaires may be provided.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* To participate in the study individuals must\n\n * be 18-50 years old.\n * be willing to complete multiple questionnaires via computer.\n * be willing to take the probiotic or placebo capsule daily for 8 weeks.\n * be willing to provide 1 stool during weeks 0, 2, 4, 8 and 12 of the study.\n * be willing to provide blood samples at weeks -1, 0, 2, 4, 8 and 12 of the study.\n * have daily access to a computer with internet access for the entire 13-wk study.\n * be willing to provide a social security number\n\nExclusion Criteria:\n\n* To participate in the study individuals must NOT\n\n * currently take medications for constipation, diarrhea or psychological disorders (depression, anxiety, insomnia etc.).\n * have taken antibiotics within the past four weeks prior to randomization.\n * currently take probiotic supplements and do not want to discontinue a minimum of two weeks prior to the study\n * have had or are currently being treated for any diseases or illnesses such as gastrointestinal disease (gastric ulcers, Crohn's, ulcerative colitis, etc.), chronic disease like diabetes or kidney disease, immune-compromising diseases or conditions (HIV, AIDS, hepatitis, cancer, transplant patient etc.)\n * currently receive medical treatment for stress induced symptoms/disorders\n * be a current smoker"}, 'identificationModule': {'nctId': 'NCT02349360', 'acronym': 'LJ', 'briefTitle': 'Safety, Tolerability and Host Response to Lactobacillus Johnsonii', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Safety, Tolerability and Host Response to Lactobacillus Johnsonii', 'orgStudyIdInfo': {'id': '201400370'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Probiotic', 'description': 'L. johnsonii N6.2 10\\^10 CFU in capsule form administered for 8 weeks', 'interventionNames': ['Biological: L. johnsonii N6.2']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Encapsulated starch placebo administered for 8 weeks', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'L. johnsonii N6.2', 'type': 'BIOLOGICAL', 'otherNames': ['Lactobacillus'], 'description': 'L. johnsonii N6.2 10\\^10 CFU in capsule form administered for 8 weeks', 'armGroupLabels': ['Probiotic']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Encapsulated starch placebo administered for 8 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida, Food Science and Human Nutrition Dept', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Wendy J Dahl, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'Juvenile Diabetes Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}