Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-01-02 @ 1:18 PM
Study NCT ID:
NCT01669603
Status:
COMPLETED
Last Update Posted:
2017-04-25
First Post:
2012-08-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Probiotic on the Innate and Adaptive Host Response to Rhinovirus (EPIARR)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003139', 'term': 'Common Cold'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rbt2n@virginia.edu', 'title': 'Ronald Turner', 'organization': 'University of Virginia'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '7 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Bifidobacterium Animalis Lactis Bl-04', 'description': 'Bifidobacterium animalis subspecies lactis Bl-04 as powder mixed into drink.\n\nBifidobacterium lactis Bl-04: The study product will be a 2\\*109 cfus of probiotic Bifidobacterium lactis Bl-04 mixed with 1g of sucrose as a carrier.', 'otherNumAtRisk': 95, 'otherNumAffected': 4, 'seriousNumAtRisk': 95, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.\n\nPlacebo: Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.', 'otherNumAtRisk': 95, 'otherNumAffected': 1, 'seriousNumAtRisk': 95, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Interleukin-8 (IL-8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bifidobacterium Animalis Lactis Bl-04', 'description': 'Bifidobacterium animalis subspecies lactis Bl-04 as powder mixed into drink.\n\nBifidobacterium lactis Bl-04: The study product will be a 2\\*109 cfus of probiotic Bifidobacterium lactis Bl-04 mixed with 1g of sucrose as a carrier.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.\n\nPlacebo: Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.'}], 'classes': [{'categories': [{'measurements': [{'value': '133', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '122', 'spread': '2.9', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '72 hours', 'description': 'Nasal lavage will be performed to collect and measure IL-8.', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bifidobacterium Animalis Lactis Bl-04', 'description': 'Bifidobacterium animalis subspecies lactis Bl-04 as powder mixed into drink.\n\nBifidobacterium lactis Bl-04: The study product will be a 2\\*109 cfus of probiotic Bifidobacterium lactis Bl-04 mixed with 1g of sucrose as a carrier.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.\n\nPlacebo: Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '95'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '38'}]}]}], 'preAssignmentDetails': '789 subjects were screened for participation. 190 subjects met all study criteria for randomization to study intervention.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Bifidobacterium Animalis Lactis Bl-04', 'description': 'Bifidobacterium animalis subspecies lactis Bl-04 as powder mixed into drink.\n\nBifidobacterium lactis Bl-04: The study product will be a 2\\*109 cfus of probiotic Bifidobacterium lactis Bl-04 mixed with 1g of sucrose as a carrier.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.\n\nPlacebo: Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}], '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': '58', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Analysis limited to participants who were susceptible to RV39, had no virus detected in nasal lavage on Day 0, were infected and completed the study.'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '22', 'spread': '6', 'groupId': 'BG000'}, {'value': '23', 'spread': '7', 'groupId': 'BG001'}, {'value': '23', 'spread': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Volunteers challenged with rhinovirus who met protocol definitions for analysis.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 789}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-20', 'studyFirstSubmitDate': '2012-08-16', 'resultsFirstSubmitDate': '2017-03-08', 'studyFirstSubmitQcDate': '2012-08-20', 'lastUpdatePostDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-20', 'studyFirstPostDateStruct': {'date': '2012-08-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interleukin-8 (IL-8)', 'timeFrame': '72 hours', 'description': 'Nasal lavage will be performed to collect and measure IL-8.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Common cold'], 'conditions': ['Common Cold']}, 'referencesModule': {'references': [{'pmid': '28343401', 'type': 'DERIVED', 'citation': 'Turner RB, Woodfolk JA, Borish L, Steinke JW, Patrie JT, Muehling LM, Lahtinen S, Lehtinen MJ. Effect of probiotic on innate inflammatory response and viral shedding in experimental rhinovirus infection - a randomised controlled trial. Benef Microbes. 2017 Apr 26;8(2):207-215. doi: 10.3920/BM2016.0160. Epub 2017 Mar 27.'}]}, 'descriptionModule': {'briefSummary': 'The study is designed to assess the effect of ingestion of a probiotic on innate and adaptive host responses to rhinovirus infection.', 'detailedDescription': 'The common cold is a ubiquitous illness of man that is associated with significant medical and socioeconomic consequences. Current treatments for the common cold that have proven efficacy are limited to pharmacologic agents that are directed at specific symptoms. These treatments- antihistamines, nasal decongestants and analgesics- have limited effectiveness, generally relieving the target symptom by 15-25% at the peak of activity, and are associated with bothersome side effects. There are no currently effective treatments for prevention of rhinovirus infections.\n\nProbiotics have been defined by FAO/WHO as "Live microorganisms which when administered in adequate amount confer a health benefit on a host." The most common probiotics belong to Lactobacillus or Bifidobacterium genera. Bifidobacteria are natural human gut inhabitants that were discovered over a hundred years ago from the feces of breast-fed infants. The study product Bifidobacterium animalis subspecies (subsp.) lactis Bl-04 (Bl-04) has been genetically characterized as B. animalis subsp. lactis by 16S rRNA gene sequencing and full genome sequence comparison. Bl-04 has been deposited in the American Type Culture Collections safe deposit as SD5219.\n\nThis study will test the hypothesis that ingestion of a probiotic Bifidobacterium animalis subsp. lactis Bl-04 will alter the innate and adaptive host response to rhinovirus infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAT ENROLLMENT:\n\n* Subject must be 18-60 years of age.\n* Subject must read and sign a copy of the approved Consent Form\n* Female subjects must be using an effective birth control method.\n\nINCLUSION CRITERIA AT DAY -28\n\n* Subject must read and sign a copy of the approved Consent Form\n\nAT CHALLENGE:\n\n* Female subjects must be using an effective birth control method.\n* Subject must have a serum neutralizing antibody titer of less than or equal to 1:4 to rhinovirus type 39\n\nExclusion Criteria:\n\nAT ENROLLMENT:\n\n* Current cancer diagnosis or immunosuppressive therapy in the last 6 months\n* Any clinically significant abnormalities of the upper respiratory tract\n* Any clinically significant acute or chronic respiratory illness\n* Any clinically significant bleeding tendency by history\n* Hypertension that requires treatment with antihypertensive medications\n* History of angina or other clinically significant cardiac disease\n* Any medical condition that in the opinion of the Principal Investigator is cause for exclusion from the study\n* History of regular use (more than 3 days in 7) of tobacco products within the preceding two weeks\n* History of drug or alcohol abuse in the 6 months preceding the study\n\nEXCLUSION CRITERIA AT DAY -28\n\n* Antibiotic use within 3 months prior to study start\n* Female subjects with a positive urine pregnancy screen.\n* History of use of probiotics in the preceding 2 weeks.\n\nEXCLUSION CRITERIA AT CHALLENGE:\n\n* Any upper respiratory infection or allergic rhinitis in the two weeks prior to the start of the study\n* Any medical condition that in the opinion of the Principal Investigator is cause for exclusion from the study\n* Use of any anti-inflammatory (steroids or NSAIDs) or cough/cold preparation in the two weeks prior to the study'}, 'identificationModule': {'nctId': 'NCT01669603', 'acronym': 'EPIARR', 'briefTitle': 'Effect of Probiotic on the Innate and Adaptive Host Response to Rhinovirus (EPIARR)', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Effect of Probiotic on the Innate and Adaptive Host Response to Rhinovirus (EPIARR)', 'orgStudyIdInfo': {'id': '16241'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bifidobacterium animalis lactis Bl-04', 'description': 'Bifidobacterium animalis subspecies lactis Bl-04 as powder mixed into drink.', 'interventionNames': ['Dietary Supplement: Bifidobacterium lactis Bl-04', 'Biological: Rhinovirus']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.', 'interventionNames': ['Dietary Supplement: Placebo', 'Biological: Rhinovirus']}], 'interventions': [{'name': 'Bifidobacterium lactis Bl-04', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The study product will be a 2\\*109 cfus of probiotic Bifidobacterium lactis Bl-04 mixed with 1g of sucrose as a carrier.', 'armGroupLabels': ['Bifidobacterium animalis lactis Bl-04']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.', 'armGroupLabels': ['Placebo']}, {'name': 'Rhinovirus', 'type': 'BIOLOGICAL', 'description': 'rhinovirus for experimental challenge', 'armGroupLabels': ['Bifidobacterium animalis lactis Bl-04', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Ronald Turner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'collaborators': [{'name': 'DuPont Nutrition and Health', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ronald Turner, MD', 'investigatorAffiliation': 'University of Virginia'}}}}