Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2025-12-26 @ 11:13 AM
Study NCT ID:
NCT00822328
Status:
COMPLETED
Last Update Posted:
2009-09-02
First Post:
2009-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Fermented Milk Drink on Human Intestinal Microflora
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'd49311001@ym.edu.tw', 'phone': '+886-2-28264400', 'title': 'Dr.Yi-Hsien Lin', 'phoneExt': '5750', 'organization': 'Cheng Hsin Rehabilitation Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Fermented Milk (Study Group)', 'description': 'Fermented milk with Lactobacillus casei strain Shirota 100ml per day', 'otherNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Unfermented Milk (Placebo Group)', 'description': 'Unfermented milk without Lactobacillus casei strain Shirota 100ml per day', 'otherNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Modification of the Composition of the Intestinal Microflora: Bifidobacterium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fermented Milk (Study Group)', 'description': 'Fermented milk with Lactobacillus casei strain Shirota 100ml per day'}, {'id': 'OG001', 'title': 'Unfermented Milk (Placebo Group)', 'description': 'Unfermented milk without Lactobacillus casei strain Shirota 100ml per day'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '7.88', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '7.60', 'spread': '0.63', 'groupId': 'OG001'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '8.13', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '8.10', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '9.03', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '8.35', 'spread': '0.59', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '8.87', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '8.11', 'spread': '0.82', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '9.43', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '8.40', 'spread': '0.52', 'groupId': 'OG001'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '9.14', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '8.27', 'spread': '0.44', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '8.51', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '8.05', 'spread': '0.63', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Bacterial colonies were counted for study group and placebo group on week 0, 1, 2, 3, 4, 5, 6. Significant differences between both experimental groups at the same time were determined with one-way ANOVA (significance level p = 0.05).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LOG_MEAN', 'timeFrame': 'week 0, 1, 2, 3, 4, 5, 6.', 'description': 'Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6. Bifidobacterium was cultured. Bacterial colonies were counted.', 'unitOfMeasure': 'log10 CFU/g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants for analysis was per protocol analysis.'}, {'type': 'SECONDARY', 'title': 'Modification of the Composition of the Intestinal Microflora: Escherichia Coli, Lactobacillus Spp., Lactobacillus Casei Shirota', 'paramType': 'LOG_MEAN', 'timeFrame': 'at week 0, 1, 2, 3, 4, 5, 6', 'description': 'Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6.\n\nBacterial colonies were cultured and counted.', 'unitOfMeasure': 'log10 CFU/g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'NOT_POSTED', 'anticipatedPostingDate': '2009-03'}, {'type': 'PRIMARY', 'title': 'Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fermented Milk (Study Group)', 'description': 'Fermented milk with Lactobacillus casei strain Shirota 100ml per day'}, {'id': 'OG001', 'title': 'Unfermented Milk (Placebo Group)', 'description': 'Unfermented milk without Lactobacillus casei strain Shirota 100ml per day'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '7.13', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '7.24', 'spread': '0.59', 'groupId': 'OG001'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '7.61', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '7.57', 'spread': '0.57', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '8.04', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '7.95', 'spread': '0.31', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '7.53', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '7.78', 'spread': '0.37', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '7.29', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '7.54', 'spread': '0.43', 'groupId': 'OG001'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '6.00', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '6.83', 'spread': '0.74', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '6.57', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '6.65', 'spread': '0.63', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Bacterial colonies were counted for study group and placebo group on week 0, 1, 2, 3, 4, 5, 6. Significant differences between both experimental groups at the same time were determined with one-way ANOVA (significance level p = 0.05).', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LOG_MEAN', 'timeFrame': 'week 0, 1, 2, 3, 4, 5, 6.', 'description': 'Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6.\n\nClostridium perfringens was cultured.Bacterial colonies were counted.', 'unitOfMeasure': 'log10 CFU/g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fermented Milk (Study Group)', 'description': 'Fermented milk with Lactobacillus casei strain Shirota 100ml per day'}, {'id': 'FG001', 'title': 'Unfermented Milk (Placebo Group)', 'description': 'Unfermented milk without Lactobacillus casei strain Shirota 100ml per day'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '24 healthy volunteers were recuited on Jan.11, 2009 at Cheng Hsin Rehabilitation Medical Center.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fermented Milk (Study Group)', 'description': 'Fermented milk with Lactobacillus casei strain Shirota 100ml per day'}, {'id': 'BG001', 'title': 'Unfermented Milk (Placebo Group)', 'description': 'Unfermented milk without Lactobacillus casei strain Shirota 100ml per day'}, {'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': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', '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': '30.00', 'spread': '3.54', 'groupId': 'BG000'}, {'value': '32.42', 'spread': '6.33', 'groupId': 'BG001'}, {'value': '31.21', 'spread': '5.17', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Taiwan', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-27', 'studyFirstSubmitDate': '2009-01-09', 'resultsFirstSubmitDate': '2009-03-23', 'studyFirstSubmitQcDate': '2009-01-13', 'lastUpdatePostDateStruct': {'date': '2009-09-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-07-08', 'studyFirstPostDateStruct': {'date': '2009-01-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modification of the Composition of the Intestinal Microflora: Bifidobacterium', 'timeFrame': 'week 0, 1, 2, 3, 4, 5, 6.', 'description': 'Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6. Bifidobacterium was cultured. Bacterial colonies were counted.'}, {'measure': 'Modification of the Composition of the Intestinal Microflora: Clostridium Perfringens', 'timeFrame': 'week 0, 1, 2, 3, 4, 5, 6.', 'description': 'Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6.\n\nClostridium perfringens was cultured.Bacterial colonies were counted.'}], 'secondaryOutcomes': [{'measure': 'Modification of the Composition of the Intestinal Microflora: Escherichia Coli, Lactobacillus Spp., Lactobacillus Casei Shirota', 'timeFrame': 'at week 0, 1, 2, 3, 4, 5, 6', 'description': 'Fecal specimens were obtained from all 24 healthy volunteers at week 0, 1, 2, 3, 4, 5, 6.\n\nBacterial colonies were cultured and counted.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Probiotics', 'Lactobacillus', 'Intestine', 'Flora'], 'conditions': ['Signs and Symptoms, Digestive']}, 'descriptionModule': {'briefSummary': 'Fermented milk is a popular drink. Recent studies revealed that some fermented milk containing some strains of lactic acid bacteria have health-promoting effects through improvement of the intestinal microflora and modulation of the immune system. Lactobacillus casei strain Shirota (LcS) is a probiotic bacterium used in the production of fermented milk products and lactic acid bacteria preparations. LcS has been shown to modify allergen-induced immune responses in allergic rhinitis, altering fermentation patterns in the small bowel, prevention of recurrent urinary tract infections in women. Yakult®300 is a fermented milk containing at least 3x10\\^10 live LcS cells per 100 ml bottle. This study aimed to evaluate the effects of a fermented milk drink containing Lactobacillus casei strain Shirota on the human intestinal microflora.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult volunteers and willing to give voluntary written informed consent\n\nExclusion Criteria:\n\n* Major systemic disease\n* Pregnancy, parturient and feeding woman, or expect to be pregnant\n* Abnormal liver function\n* Abnormal renal function\n* Abnormal gastrointestinal function\n* Take medication for gastrointestinal function\n* Stroke, myocardial infarction,\n* Poor compliance for study protocol'}, 'identificationModule': {'nctId': 'NCT00822328', 'briefTitle': 'Fermented Milk Drink on Human Intestinal Microflora', 'organization': {'class': 'OTHER', 'fullName': 'Cheng Hsin Rehabilitation Medical Center'}, 'officialTitle': 'Effects of a Fermented Milk Drink Containing Lactobacillus Casei Strain Shirota on the Human Intestinal Microflora', 'orgStudyIdInfo': {'id': 'CHGH-IRB(173)97B-13-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Fermented milk with Lactobacillus casei strain Shirota 100ml per day', 'interventionNames': ['Dietary Supplement: Yakult®300', 'Dietary Supplement: Lactobacillus casei strain Shirota']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Unfermented milk without Lactobacillus casei strain Shirota 100ml per day', 'interventionNames': ['Dietary Supplement: Yakult®300']}], 'interventions': [{'name': 'Yakult®300', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Yakult®300 was given 100 ml once per day for four weeks.\n\nFermented or unfermented milk per 100 ml bottle per day for four week.', 'armGroupLabels': ['1', '2']}, {'name': 'Lactobacillus casei strain Shirota', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Lactobacillus casei strain Shirota', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '112', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Division of Radiotherapy, Cheng Hsin Rehabilitation Medical Center', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Yi-Hsien Lin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Radiotherapy, Cheng Hsin Rehabilitation Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cheng Hsin Rehabilitation Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Yi-Hsien Lin', 'oldOrganization': 'Division of Radiotherapy, Cheng Hsin Rehabilitation Medical Center'}}}}