Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-27 @ 1:10 AM
Study NCT ID:
NCT01657032
Status:
COMPLETED
Last Update Posted:
2014-04-01
First Post:
2012-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of Lactobacillus GG With Diosmectite in Treatment Children With Acute Gastroenteritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003967', 'term': 'Diarrhea'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C033214', 'term': 'Smectite'}, {'id': 'C016752', 'term': 'smecta'}, {'id': 'D005947', 'term': 'Glucose'}], 'ancestors': [{'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hania@ipgate.pl', 'phone': '+48-22-45-23-309', 'title': 'Hanna Szajewska, Malgorzata Pieścik-Lech', 'organization': 'The Medical University of Warsaw'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'A potential limitation of our study is the lack of perfect blinding. Patients received smectite or placebo in identical packages from the hospital pharmacy. After being dissolved in water, they were of different colors.'}}, 'adverseEventsModule': {'timeFrame': '7days', 'eventGroups': [{'id': 'EG000', 'title': 'Lactobacillus GG and Smectite', 'description': 'Children received:\n\n* LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and\n* smectite, dose 3 g, once daily orally until diarrhea stopped\n\nSmectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.\n\nLactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite', 'otherNumAtRisk': 44, 'otherNumAffected': 0, 'seriousNumAtRisk': 44, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Lactobacillus GG and Placebo', 'description': 'Children received:\n\n* LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and\n* placebo (glucose), dose 3 g, once daily orally until diarrhea stopped\n\nPlacebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.\n\nLactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite', 'otherNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Duration of Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus GG and Smectite', 'description': 'Children received:\n\n* LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and\n* smectite, dose 3 g, once daily orally until diarrhea stopped\n\nSmectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.\n\nLactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite'}, {'id': 'OG001', 'title': 'Lactobacillus GG and Placebo', 'description': 'Children received:\n\n* LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and\n* placebo (glucose), dose 3 g, once daily orally until diarrhea stopped\n\nPlacebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.\n\nLactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '2'}]}]}], 'analyses': [{'pValue': '0.43', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The differences between the study groups were considered significant when the P value was \\<0.05.'}], 'paramType': 'MEDIAN', 'timeFrame': 'counted in days during 7days', 'description': 'The primary outcome measure is duration of diarrhea (counted in days; from the first loose stool to the last one; end of diarrhea defined as last loose stool or at least 12hours without stool).', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Frequency of Loose Stools,', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus GG and Smectite', 'description': 'Children received:\n\n* LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and\n* smectite, dose 3 g, once daily orally until diarrhea stopped\n\nSmectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.\n\nLactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite'}, {'id': 'OG001', 'title': 'Lactobacillus GG and Placebo', 'description': 'Children received:\n\n* LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and\n* placebo (glucose), dose 3 g, once daily orally until diarrhea stopped\n\nPlacebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.\n\nLactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite'}], 'classes': [{'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '21'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '15'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'number of loose stools during 7 days', 'description': 'number of loose stools during 7 days', 'unitOfMeasure': 'number of loose stools during 7days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Consistency of Stools', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus GG and Smectite', 'description': 'Children received:\n\n* LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and\n* smectite, dose 3 g, once daily orally until diarrhea stopped\n\nSmectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.\n\nLactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite'}, {'id': 'OG001', 'title': 'Lactobacillus GG and Placebo', 'description': 'Children received:\n\n* LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and\n* placebo (glucose), dose 3 g, once daily orally until diarrhea stopped\n\nPlacebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.\n\nLactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '6'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'day 4-th', 'description': 'consistency of stools using Bristool Stool Scale Form on day 4-th. (The Bristol stool scale form is a medical aid designed to classify the form of human faeces into seven categories.\n\nType 1 Separate hard lumps, like nuts (hard to pass) Type 2 Sausage-shaped but lumpy Type 3 Like a sausage but with cracks on the surface Type 4 Like a sausage or snake, smooth and soft Type 5 Soft blobs with clear-cut edges Type 6 Fluffy pieces with ragged edges, a mushy stool Type 7 Watery, no solid pieces. Entirely liquid Types 1-2 indicate constipation, with 3 and 4 being the ideal stools (especially the latter), as they are easy to defecate while not containing any excess liquid, and 5, 6 and 7 tending towards diarrhoea.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Need for Antibiotic Therapy,', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus GG and Smectite', 'description': 'Children received:\n\n* LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and\n* smectite, dose 3 g, once daily orally until diarrhea stopped\n\nSmectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.\n\nLactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite'}, {'id': 'OG001', 'title': 'Lactobacillus GG and Placebo', 'description': 'Children received:\n\n* LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and\n* placebo (glucose), dose 3 g, once daily orally until diarrhea stopped\n\nPlacebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.\n\nLactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'yes/no, for 7days', 'description': 'need for antibiotic therapy because of diarrhea', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus GG and Smectite', 'description': 'Children received:\n\n* LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and\n* smectite, dose 3 g, once daily orally until diarrhea stopped\n\nSmectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.\n\nLactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite'}, {'id': 'OG001', 'title': 'Lactobacillus GG and Placebo', 'description': 'Children received:\n\n* LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and\n* placebo (glucose), dose 3 g, once daily orally until diarrhea stopped\n\nPlacebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.\n\nLactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'yes/no, for 7days', 'description': 'If the child vomiting after randomization (yes/no)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus GG and Smectite', 'description': 'Children received:\n\n* LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and\n* smectite, dose 3 g, once daily orally until diarrhea stopped\n\nSmectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.\n\nLactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite'}, {'id': 'OG001', 'title': 'Lactobacillus GG and Placebo', 'description': 'Children received:\n\n* LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and\n* placebo (glucose), dose 3 g, once daily orally until diarrhea stopped\n\nPlacebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.\n\nLactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'how many times for 7days', 'description': 'How many times the child was vomiting (during the study)', 'unitOfMeasure': 'vomiting episodes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Diarrhea Recurrence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus GG and Smectite', 'description': 'Children received:\n\n* LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and\n* smectite, dose 3 g, once daily orally until diarrhea stopped\n\nSmectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.\n\nLactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite'}, {'id': 'OG001', 'title': 'Lactobacillus GG and Placebo', 'description': 'Children received:\n\n* LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and\n* placebo (glucose), dose 3 g, once daily orally until diarrhea stopped\n\nPlacebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.\n\nLactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days', 'description': 'If the was a diarrhea recurrence during 7days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Tolerance of Products', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus GG and Smectite', 'description': 'Children received:\n\n* LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and\n* smectite, dose 3 g, once daily orally until diarrhea stopped\n\nSmectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.\n\nLactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite'}, {'id': 'OG001', 'title': 'Lactobacillus GG and Placebo', 'description': 'Children received:\n\n* LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and\n* placebo (glucose), dose 3 g, once daily orally until diarrhea stopped\n\nPlacebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.\n\nLactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7days', 'description': 'tolerance of products (whether the child took medicaments),', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Need for Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus GG and Smectite', 'description': 'Children received:\n\n* LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and\n* smectite, dose 3 g, once daily orally until diarrhea stopped\n\nSmectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.\n\nLactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite'}, {'id': 'OG001', 'title': 'Lactobacillus GG and Placebo', 'description': 'Children received:\n\n* LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and\n* placebo (glucose), dose 3 g, once daily orally until diarrhea stopped\n\nPlacebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.\n\nLactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days', 'description': 'If the child need to hospitalized', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Need for Intravenous Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus GG and Smectite', 'description': 'Children received:\n\n* LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and\n* smectite, dose 3 g, once daily orally until diarrhea stopped\n\nSmectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.\n\nLactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite'}, {'id': 'OG001', 'title': 'Lactobacillus GG and Placebo', 'description': 'Children received:\n\n* LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and\n* placebo (glucose), dose 3 g, once daily orally until diarrhea stopped\n\nPlacebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.\n\nLactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'yes/no, for 7days', 'description': 'need for intravenous rehydration therapy (yes/no)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Intravenous Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus GG and Smectite', 'description': 'Children received:\n\n* LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and\n* smectite, dose 3 g, once daily orally until diarrhea stopped\n\nSmectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.\n\nLactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite'}, {'id': 'OG001', 'title': 'Lactobacillus GG and Placebo', 'description': 'Children received:\n\n* LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and\n* placebo (glucose), dose 3 g, once daily orally until diarrhea stopped\n\nPlacebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.\n\nLactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '7days', 'description': 'need for intravenous rehydration therapy (how long if needed)', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lactobacillus GG and Smectite', 'description': 'Children received:\n\n* LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and\n* smectite, dose 3 g, once daily orally until diarrhea stopped\n\nSmectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.\n\nLactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite'}, {'id': 'FG001', 'title': 'Lactobacillus GG and Placebo', 'description': 'Children received:\n\n* LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and\n* placebo (glucose), dose 3 g, once daily orally until diarrhea stopped\n\nPlacebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.\n\nLactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lactobacillus GG and Smectite', 'description': 'Children received:\n\n* LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and\n* smectite, dose 3 g, once daily orally until diarrhea stopped\n\nSmectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.\n\nLactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite'}, {'id': 'BG001', 'title': 'Lactobacillus GG and Placebo', 'description': 'Children received:\n\n* LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and\n* placebo (glucose), dose 3 g, once daily orally until diarrhea stopped\n\nPlacebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.\n\nLactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '17.5', 'groupId': 'BG000', 'lowerLimit': '10.0', 'upperLimit': '22.5'}, {'value': '18', 'groupId': 'BG001', 'lowerLimit': '11', 'upperLimit': '30'}, {'value': '18', 'groupId': 'BG002', 'lowerLimit': '10', 'upperLimit': '23'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'months', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Poland', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-14', 'studyFirstSubmitDate': '2012-07-05', 'resultsFirstSubmitDate': '2013-11-20', 'studyFirstSubmitQcDate': '2012-08-02', 'lastUpdatePostDateStruct': {'date': '2014-04-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-02-14', 'studyFirstPostDateStruct': {'date': '2012-08-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of Diarrhea', 'timeFrame': 'counted in days during 7days', 'description': 'The primary outcome measure is duration of diarrhea (counted in days; from the first loose stool to the last one; end of diarrhea defined as last loose stool or at least 12hours without stool).'}], 'secondaryOutcomes': [{'measure': 'Frequency of Loose Stools,', 'timeFrame': 'number of loose stools during 7 days', 'description': 'number of loose stools during 7 days'}, {'measure': 'Consistency of Stools', 'timeFrame': 'day 4-th', 'description': 'consistency of stools using Bristool Stool Scale Form on day 4-th. (The Bristol stool scale form is a medical aid designed to classify the form of human faeces into seven categories.\n\nType 1 Separate hard lumps, like nuts (hard to pass) Type 2 Sausage-shaped but lumpy Type 3 Like a sausage but with cracks on the surface Type 4 Like a sausage or snake, smooth and soft Type 5 Soft blobs with clear-cut edges Type 6 Fluffy pieces with ragged edges, a mushy stool Type 7 Watery, no solid pieces. Entirely liquid Types 1-2 indicate constipation, with 3 and 4 being the ideal stools (especially the latter), as they are easy to defecate while not containing any excess liquid, and 5, 6 and 7 tending towards diarrhoea.'}, {'measure': 'Need for Antibiotic Therapy,', 'timeFrame': 'yes/no, for 7days', 'description': 'need for antibiotic therapy because of diarrhea'}, {'measure': 'Vomiting', 'timeFrame': 'yes/no, for 7days', 'description': 'If the child vomiting after randomization (yes/no)'}, {'measure': 'Vomiting', 'timeFrame': 'how many times for 7days', 'description': 'How many times the child was vomiting (during the study)'}, {'measure': 'Diarrhea Recurrence', 'timeFrame': '7 days', 'description': 'If the was a diarrhea recurrence during 7days'}, {'measure': 'Tolerance of Products', 'timeFrame': '7days', 'description': 'tolerance of products (whether the child took medicaments),'}, {'measure': 'Need for Hospitalization', 'timeFrame': '7 days', 'description': 'If the child need to hospitalized'}, {'measure': 'Need for Intravenous Therapy', 'timeFrame': 'yes/no, for 7days', 'description': 'need for intravenous rehydration therapy (yes/no)'}, {'measure': 'Duration of Intravenous Therapy', 'timeFrame': '7days', 'description': 'need for intravenous rehydration therapy (how long if needed)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['diarrhea', 'probiotics', 'diosmectite'], 'conditions': ['Diarrhea']}, 'referencesModule': {'references': [{'pmid': '18493225', 'type': 'BACKGROUND', 'citation': 'Guarino A, Albano F, Ashkenazi S, Gendrel D, Hoekstra JH, Shamir R, Szajewska H; ESPGHAN/ESPID Evidence-Based Guidelines for the Management of Acute Gastroenteritis in Children in Europe Expert Working Group. European Society for Paediatric Gastroenterology, Hepatology, and Nutrition/European Society for Paediatric Infectious Diseases evidence-based guidelines for the management of acute gastroenteritis in children in Europe: executive summary. J Pediatr Gastroenterol Nutr. 2008 May;46(5):619-21. doi: 10.1097/MPG.0b013e31816e219e. No abstract available.'}, {'pmid': '9553803', 'type': 'BACKGROUND', 'citation': 'Guarner F, Schaafsma GJ. Probiotics. Int J Food Microbiol. 1998 Feb 17;39(3):237-8. doi: 10.1016/s0168-1605(97)00136-0. No abstract available.'}, {'pmid': '17402990', 'type': 'BACKGROUND', 'citation': 'Szajewska H, Skorka A, Ruszczynski M, Gieruszczak-Bialek D. Meta-analysis: Lactobacillus GG for treating acute diarrhoea in children. Aliment Pharmacol Ther. 2007 Apr 15;25(8):871-81. doi: 10.1111/j.1365-2036.2007.03282.x.'}, {'pmid': '16393300', 'type': 'BACKGROUND', 'citation': 'Szajewska H, Dziechciarz P, Mrukowicz J. Meta-analysis: Smectite in the treatment of acute infectious diarrhoea in children. Aliment Pharmacol Ther. 2006 Jan 15;23(2):217-27. doi: 10.1111/j.1365-2036.2006.02760.x.'}]}, 'descriptionModule': {'briefSummary': 'Treatment diarrhea with Lactobacillus GG or smectite has proven efficacy. A randomized, double blind, placebo-control trial was performed to assess the effectiveness of both LGG and smectite in management of children with acute gastroenteritis (AGE).', 'detailedDescription': 'ESPGHAN agreed to use probiotics, with proven efficacy, and smectite in treatment of AGE as an adjunct to standard rehydration therapy. Among probiotics Lactobacillus GG were found to be beneficial in meta-analyses. Treatment with LGG was associated with a significant reduction in diarrhea duration.\n\nA recent review systematically evaluated the efficacy of smectite in treating acute infections diarrhea in infants and children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children \\< 5 years old\n* diarrhea (defined as the passage of 3 or more loose or watery stools per day) for \\> 1 day but \\< 5 days\n* inform consent sing\n\nExclusion Criteria:\n\n* diarrhea \\< 1 or \\> 5 days,\n* a recent history of diarrhea indicated either by parents/guardian or hospital case notes,\n* underlying chronic gastrointestinal disease,\n* undernutrition (weight/height ratio below the 5th percentile),\n* systematic infection,\n* immune defects or immunosuppressive treatment'}, 'identificationModule': {'nctId': 'NCT01657032', 'briefTitle': 'Efficacy of Lactobacillus GG With Diosmectite in Treatment Children With Acute Gastroenteritis', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Warsaw'}, 'officialTitle': 'Efficacy of Lactobacillus GG With Diosmectite in Treatment Children With Acute Gastroenteritis: A Double Blind Randomized, Placebo- Controlled Trial', 'orgStudyIdInfo': {'id': 'KB2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lactobacillus GG and Smectite', 'description': 'Children received:\n\n* LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and\n* smectite, dose 3 g, once daily orally until diarrhea stopped', 'interventionNames': ['Dietary Supplement: Smectite', 'Dietary Supplement: Lactobacillus GG']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Lactobacillus GG and Placebo', 'description': 'Children received:\n\n* LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and\n* placebo (glucose), dose 3 g, once daily orally until diarrhea stopped', 'interventionNames': ['Dietary Supplement: Placebo', 'Dietary Supplement: Lactobacillus GG']}], 'interventions': [{'name': 'Smectite', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Smecta'], 'description': 'Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.', 'armGroupLabels': ['Lactobacillus GG and Smectite']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['glucose'], 'description': 'Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.', 'armGroupLabels': ['Lactobacillus GG and Placebo']}, {'name': 'Lactobacillus GG', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Dicoflor 30'], 'description': 'All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite', 'armGroupLabels': ['Lactobacillus GG and Placebo', 'Lactobacillus GG and Smectite']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01-183', 'city': 'Warsaw', 'state': 'Warsaw', 'country': 'Poland', 'facility': 'Department of Paediatrics, The Medical University of Warsaw', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Warsaw', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}