Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:47 PM
Study NCT ID:
NCT01773967
Status:
COMPLETED
Last Update Posted:
2019-09-06
First Post:
2013-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Impact of Emergency Department Probiotic (LGG) Treatment of Pediatric Gastroenteritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005759', 'term': 'Gastroenteritis'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'david.schnadower@cchmc.org', 'phone': '5138035526', 'title': 'Dr. David Schnadower', 'organization': "Cincinnati Children's Hospital Medical Center"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '35 days, long term follow up 1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Lactobacillus Rhamnosus GG', 'description': 'LGG 10\\^10 cfu PO bid x 5 days\n\nLGG: LGG 10\\^10 cfu PO BID X 5 days', 'otherNumAtRisk': 483, 'deathsNumAtRisk': 483, 'otherNumAffected': 55, 'seriousNumAtRisk': 483, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Placebo', 'description': 'micro-crystalline cellulose PO bid x 5 days\n\nmicro-crystalline cellulose: 1 capsule PO bid x 5 days', 'otherNumAtRisk': 488, 'deathsNumAtRisk': 488, 'otherNumAffected': 49, 'seriousNumAtRisk': 488, 'deathsNumAffected': 0, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numEvents': 40, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 488, 'numEvents': 35, 'numAffected': 35}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 488, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Worsening diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 488, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 488, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'seizure', 'notes': 'febrile', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 488, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 488, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'lower respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 488, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 488, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 488, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 488, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 483, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 488, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Modified Vesikari Scale Score >=9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '468', 'groupId': 'OG000'}, {'value': '475', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus Rhamnosus GG', 'description': 'LGG 10\\^10 cfu PO bid x 5 days\n\nLGG: LGG 10\\^10 cfu PO BID X 5 days'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'micro-crystalline cellulose PO bid x 5 days\n\nmicro-crystalline cellulose: 1 capsule PO bid x 5 days'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.83', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 days', 'description': 'This is a validated gastroenteritis severity score that includes duration and frequency of diarrhea, duration and frequency of vomiting, duration and frequency of fever and use of health care resources. Scores \\>=9 indicate moderate-severe gastroenteritis. Higher is worse.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With LGG Bacteremia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '468', 'groupId': 'OG000'}, {'value': '475', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus Rhamnosus GG', 'description': 'LGG 10\\^10 cfu PO bid x 5 days\n\nLGG: LGG 10\\^10 cfu PO BID X 5 days'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'micro-crystalline cellulose PO bid x 5 days\n\nmicro-crystalline cellulose: 1 capsule PO bid x 5 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 month', 'description': 'bacteremia caused by LGG', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diarrhea Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '468', 'groupId': 'OG000'}, {'value': '475', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus Rhamnosus GG', 'description': 'LGG 10\\^10 cfu PO bid x 5 days\n\nLGG: LGG 10\\^10 cfu PO BID X 5 days'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'micro-crystalline cellulose PO bid x 5 days\n\nmicro-crystalline cellulose: 1 capsule PO bid x 5 days'}], 'classes': [{'categories': [{'measurements': [{'value': '49.7', 'groupId': 'OG000', 'lowerLimit': '18.8', 'upperLimit': '86.4'}, {'value': '50.9', 'groupId': 'OG001', 'lowerLimit': '25.0', 'upperLimit': '88.2'}]}]}], 'analyses': [{'pValue': '0.26', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': "Van Elteren's modification Mann-Whitney", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '14 days', 'description': 'diarrhea duration in hours after randomization', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lactobacillus Rhamnosus GG', 'description': 'LGG 10\\^10 cfu PO bid x 5 days\n\nLGG: LGG 10\\^10 cfu PO BID X 5 days'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'micro-crystalline cellulose PO bid x 5 days\n\nmicro-crystalline cellulose: 1 capsule PO bid x 5 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '483'}, {'groupId': 'FG001', 'numSubjects': '488'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '468'}, {'groupId': 'FG001', 'numSubjects': '475'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '13'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '483', 'groupId': 'BG000'}, {'value': '488', 'groupId': 'BG001'}, {'value': '971', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lactobacillus Rhamnosus GG', 'description': 'LGG 10\\^10 cfu PO bid x 5 days\n\nLGG: LGG 10\\^10 cfu PO BID X 5 days'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'micro-crystalline cellulose PO bid x 5 days\n\nmicro-crystalline cellulose: 1 capsule PO bid x 5 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'groupId': 'BG000', 'lowerLimit': '0.9', 'upperLimit': '2.4'}, {'value': '1.4', 'groupId': 'BG001', 'lowerLimit': '0.8', 'upperLimit': '2.3'}, {'value': '1.4', 'groupId': 'BG002', 'lowerLimit': '0.9', 'upperLimit': '2.3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '236', 'groupId': 'BG000'}, {'value': '222', 'groupId': 'BG001'}, {'value': '458', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '247', 'groupId': 'BG000'}, {'value': '266', 'groupId': 'BG001'}, {'value': '513', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '176', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '338', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '307', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '259', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '483', 'groupId': 'BG000'}, {'value': '488', 'groupId': 'BG001'}, {'value': '971', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Median Modified Vesikari Scale score at presentation', 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000', 'lowerLimit': '10', 'upperLimit': '14'}, {'value': '12', 'groupId': 'BG001', 'lowerLimit': '9', 'upperLimit': '14'}, {'value': '12', 'groupId': 'BG002', 'lowerLimit': '10', 'upperLimit': '14'}]}]}], 'paramType': 'MEDIAN', 'description': 'The modified Vesikari scale is a validated global gastroenteritis severity scale that includes duration and severity of vomiting and diarrhea, maximum recorded temperature, unscheduled health care visits and types of treatment received. Scores range from 0 to 20, with higher scores indicating more severe disease). A score of 9 or greater is considred moderate to severe gastroenteritis', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-04-06', 'size': 2081897, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-06-25T16:39', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 971}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-13', 'studyFirstSubmitDate': '2013-01-10', 'resultsFirstSubmitDate': '2019-06-25', 'studyFirstSubmitQcDate': '2013-01-18', 'lastUpdatePostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-13', 'studyFirstPostDateStruct': {'date': '2013-01-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Modified Vesikari Scale Score >=9', 'timeFrame': '14 days', 'description': 'This is a validated gastroenteritis severity score that includes duration and frequency of diarrhea, duration and frequency of vomiting, duration and frequency of fever and use of health care resources. Scores \\>=9 indicate moderate-severe gastroenteritis. Higher is worse.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With LGG Bacteremia', 'timeFrame': '1 month', 'description': 'bacteremia caused by LGG'}, {'measure': 'Diarrhea Duration', 'timeFrame': '14 days', 'description': 'diarrhea duration in hours after randomization'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lactobacillus rhamnosus GG', 'LGG', 'Probiotic', 'Gastroenteritis', 'acute gastroenteritis', 'child', 'pediatric', 'RCT'], 'conditions': ['Gastroenteritis']}, 'referencesModule': {'references': [{'pmid': '34596225', 'type': 'DERIVED', 'citation': "Freedman SB, Finkelstein Y, Pang XL, Chui L, Tarr PI, VanBuren JM, Olsen C, Lee BE, Hall-Moore CA, Sapien R, O'Connell K, Levine AC, Poonai N, Roskind C, Schuh S, Rogers A, Bhatt S, Gouin S, Mahajan P, Vance C, Hurley K, Powell EC, Farion KJ, Schnadower D. Pathogen-Specific Effects of Probiotics in Children With Acute Gastroenteritis Seeking Emergency Care: A Randomized Trial. Clin Infect Dis. 2022 Aug 24;75(1):55-64. doi: 10.1093/cid/ciab876."}, {'pmid': '34183579', 'type': 'DERIVED', 'citation': "Schnadower D, O'Connell KJ, VanBuren JM, Vance C, Tarr PI, Schuh S, Hurley K, Rogers AJ, Poonai N, Roskind CG, Bhatt SR, Gouin S, Mahajan P, Olsen CS, Powell EC, Farion K, Sapien RE, Chun TH, Freedman SB; Pediatric Emergency Care Applied Research Network and Pediatric Emergency Research Canada. Association Between Diarrhea Duration and Severity and Probiotic Efficacy in Children With Acute Gastroenteritis. Am J Gastroenterol. 2021 Jul 1;116(7):1523-1532. doi: 10.14309/ajg.0000000000001295."}, {'pmid': '34016656', 'type': 'DERIVED', 'citation': "Freedman SB, Roskind CG, Schuh S, VanBuren JM, Norris JG, Tarr PI, Hurley K, Levine AC, Rogers A, Bhatt S, Gouin S, Mahajan P, Vance C, Powell EC, Farion KJ, Sapien R, O'Connell K, Poonai N, Schnadower D; Pediatric Emergency Research Canada and Pediatric Emergency Care Applied Research Networks. Comparing Pediatric Gastroenteritis Emergency Department Care in Canada and the United States. Pediatrics. 2021 Jun;147(6):e2020030890. doi: 10.1542/peds.2020-030890. Epub 2021 May 20."}, {'pmid': '33871616', 'type': 'DERIVED', 'citation': "Poonai N, Powell EC, Schnadower D, Casper TC, Roskind CG, Olsen CS, Tarr PI, Mahajan P, Rogers AJ, Schuh S, Hurley KF, Gouin S, Vance C, Farion KJ, Sapien RE, O'Connell KJ, Levine AC, Bhatt S, Freedman SB; Pediatric Emergency Care Applied Research Network (PECARN) and Pediatric Emergency Research Canada (PERC). Variables Associated With Intravenous Rehydration and Hospitalization in Children With Acute Gastroenteritis: A Secondary Analysis of 2 Randomized Clinical Trials. JAMA Netw Open. 2021 Apr 1;4(4):e216433. doi: 10.1001/jamanetworkopen.2021.6433."}, {'pmid': '33274370', 'type': 'DERIVED', 'citation': "Schnadower D, Sapien RE, Casper TC, Vance C, Tarr PI, O'Connell KJ, Levine AC, Roskind CG, Rogers AJ, Bhatt SR, Mahajan P, Powell EC, Olsen CS, Gorelick MH, Dean JM, Freedman SB; Pediatric Emergency Care Applied Research Network (PECARN) Probiotics Study. Association between Age, Weight, and Dose and Clinical Response to Probiotics in Children with Acute Gastroenteritis. J Nutr. 2021 Jan 4;151(1):65-72. doi: 10.1093/jn/nxaa313."}, {'pmid': '30462938', 'type': 'DERIVED', 'citation': "Schnadower D, Tarr PI, Casper TC, Gorelick MH, Dean JM, O'Connell KJ, Mahajan P, Levine AC, Bhatt SR, Roskind CG, Powell EC, Rogers AJ, Vance C, Sapien RE, Olsen CS, Metheney M, Dickey VP, Hall-Moore C, Freedman SB. Lactobacillus rhamnosus GG versus Placebo for Acute Gastroenteritis in Children. N Engl J Med. 2018 Nov 22;379(21):2002-2014. doi: 10.1056/NEJMoa1802598."}, {'pmid': '28947466', 'type': 'DERIVED', 'citation': "Schnadower D, Tarr PI, Casper TC, Gorelick MH, Dean MJ, O'Connell KJ, Mahajan P, Chun TH, Bhatt SR, Roskind CG, Powell EC, Rogers AJ, Vance C, Sapien RE, Gao F, Freedman SB. Randomised controlled trial of Lactobacillus rhamnosus (LGG) versus placebo in children presenting to the emergency department with acute gastroenteritis: the PECARN probiotic study protocol. BMJ Open. 2017 Sep 24;7(9):e018115. doi: 10.1136/bmjopen-2017-018115."}, {'pmid': '24885220', 'type': 'DERIVED', 'citation': 'Freedman SB, Williamson-Urquhart S, Schuh S, Sherman PM, Farion KJ, Gouin S, Willan AR, Goeree R, Johnson DW, Black K, Schnadower D, Gorelick MH; Pediatric Emergency Research Canada (PERC) Gastroenteritis Study Group. Impact of emergency department probiotic treatment of pediatric gastroenteritis: study protocol for the PROGUT (Probiotic Regimen for Outpatient Gastroenteritis Utility of Treatment) randomized controlled trial. Trials. 2014 May 14;15:170. doi: 10.1186/1745-6215-15-170.'}]}, 'descriptionModule': {'briefSummary': 'The investigators will study the efficacy and side effect profile of LGG, a probiotic, in pediatric patients with acute gastroenteritis.', 'detailedDescription': 'Multicenter randomized controlled trial of LGG in patients 3-48 months of age presenting to the Emergency Department with acute gastroenteritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '48 Months', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 3-48 months (have not yet reached their fourth birthday); AND\n2. Presence of 3 or more watery stools within 24 hours of screening; AND\n3. Duration of vomiting or diarrhea less than 7 days; AND\n4. Symptoms consistent with acute intestinal infectious process.\n\nExclusion Criteria:\n\n1. Presence of an indwelling vascular access line; OR\n2. Presence of structural heart disease excluding non-pathological heart murmurs; OR\n3. Receiving immunosuppressive therapy or history of immunodeficiency; OR\n4. Hematochezia in the preceding 48 hours; OR\n5. Chronic gastrointestinal problems (e.g. short gut syndrome, inflammatory bowel disease); OR\n6. Patients with known pancreatitis; OR\n7. History of abdominal surgery; OR\n8. Critically ill patients; OR\n9. Family member with an indwelling vascular access line, or on immunosuppressive therapy, or with a known immunodeficiency; OR\n10. Bilious emesis; OR\n11. Probiotic use (supplement) in the preceding 2 weeks; OR\n12. Oral or intravenous steroid use in the preceding six months; OR\n13. Previously enrolled in this trial; OR\n14. Allergy to lactobacillus or Microcrystalline Cellulose (MCC); OR\n15. Allergy to erythromycin, clindamycin, AND betalactam antibiotics (all); OR\n16. Not available for daily follow-up while symptomatic; OR\n17. Parent/guardian not speaking English or Spanish; OR\n18. Under 6 months old AND premature (\\<37 weeks).'}, 'identificationModule': {'nctId': 'NCT01773967', 'briefTitle': 'Impact of Emergency Department Probiotic (LGG) Treatment of Pediatric Gastroenteritis', 'nctIdAliases': ['NCT00970164'], 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Impact of Emergency Department Probiotic (LGG) Treatment of Pediatric Gastroenteritis', 'orgStudyIdInfo': {'id': '1R01HD071915', 'link': 'https://reporter.nih.gov/quickSearch/1R01HD071915', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LGG', 'description': 'LGG 10\\^10 cfu PO bid x 5 days', 'interventionNames': ['Drug: LGG']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'micro-crystalline cellulose PO bid x 5 days', 'interventionNames': ['Drug: micro-crystalline cellulose']}], 'interventions': [{'name': 'LGG', 'type': 'DRUG', 'otherNames': ['Lactobacillus GG ATCC 53103', 'Lactobacillus rhamnosus', 'culturelle'], 'description': 'LGG 10\\^10 cfu PO BID X 5 days', 'armGroupLabels': ['LGG']}, {'name': 'micro-crystalline cellulose', 'type': 'DRUG', 'otherNames': ['placebo micro-crystalline cellulose'], 'description': '1 capsule PO bid x 5 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Medical Center", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Lurie Children's Hospital", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Health System', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': "Children's Hospital of Michigan", 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "St. Louis Children's Hospital", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '87106', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "Children's Hospital of New York", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': "Hasbro Children's Hospital", 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Kimberly Quayle, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Columbia University', 'class': 'OTHER'}, {'name': 'Northwestern University', 'class': 'OTHER'}, {'name': 'University of New Mexico', 'class': 'OTHER'}, {'name': "Children's National Research Institute", 'class': 'OTHER'}, {'name': 'University of Utah', 'class': 'OTHER'}, {'name': 'Wayne State University', 'class': 'OTHER'}, {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, {'name': 'University of Michigan', 'class': 'OTHER'}, {'name': 'Brown University', 'class': 'OTHER'}, {'name': 'University of California, Davis', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}