Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-02-20 @ 1:33 PM
Study NCT ID:
NCT01058356
Status:
COMPLETED
Last Update Posted:
2010-04-20
First Post:
2010-01-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Probiotic Lactobacilli (Lacidofil Cap®) for the Prevention of Antibiotic-Associated Diarrhea
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004761', 'term': 'Enterocolitis, Pseudomembranous'}], 'ancestors': [{'id': 'D003015', 'term': 'Clostridium Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004760', 'term': 'Enterocolitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pharmbio@hotmail.com', 'phone': '82-2-587-2551', 'title': 'Korea Association for the Study of Intestinal Disease (KASID)', 'organization': 'Pharmbio Korea Co., Ltd.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Lacidofil Capsule Versus Placebo Drug', 'description': 'Lacidofil capsule: Lactobacillus rhamnosus R0011‧Lactobacillus acidophilus R0052 bacterial culture (2x109), maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) Placebo drug: maltodextrin, Mg stearate, ascorbic acid\n\n(1 capsule twice a day for 14 days)', 'otherNumAtRisk': 214, 'otherNumAffected': 0, 'seriousNumAtRisk': 214, 'seriousNumAffected': 0}], 'frequencyThreshold': '2.3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Presence of AAD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacidofil Capsule Versus Placebo Drug', 'description': 'Lacidofil capsule: Lactobacillus rhamnosus R0011‧Lactobacillus acidophilus R0052 bacterial culture (2x109), maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) Placebo drug: maltodextrin, Mg stearate, ascorbic acid\n\n(1 capsule twice a day for 14 days)'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.17', 'ciUpperLimit': '4.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.40', 'groupDescription': 'Null hypothesis: The efficay of the probiotic Lactobacilli (Lacidofil cap®) for the prevention of AAD in adults is not different form the placebo group in multi-center, randomized, placebo-controlled, double-blind trial.\n\nPower calculation:\n\nThe assumption of sample size calculation:\n\ndifference 18% (8% : 26%) α: 0.05, statistical power: 90%, two sided difference: 18% Compliance: 80%\n\n\\- Unadjusted sample size (N=200) 180 + 10(%) drop out = 180 + 180/ (1-0.1)2 = 222.2 Total 220 subjects', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 14 days', 'description': 'AAD defined as: Watery stools more than 3 times per day for at least 2 days.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Presence of Bowel Habit Change (Watery Stools More Than 2 Times Per Day for at Least 2 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lacidofil Capsule Versus Placebo Drug', 'description': 'Lacidofil capsule: Lactobacillus rhamnosus R0011‧Lactobacillus acidophilus R0052 bacterial culture (2x109), maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) Placebo drug: maltodextrin, Mg stearate, ascorbic acid\n\n(1 capsule twice a day for 14 days)'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.18', 'ciUpperLimit': '1.55', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.27', 'groupDescription': 'Null hypothesis: The efficay of the probiotic Lactobacilli (Lacidofil cap®) for the prevention of AAD in adults is not different form the placebo group in multi-center, randomized, placebo-controlled, double-blind trial.\n\nPower calculation:\n\nThe assumption of sample size calculation:\n\ndifference 18% (8% : 26%) α: 0.05, statistical power: 90%, two sided difference: 18% Compliance: 80%\n\n\\- Unadjusted sample size (N=200) 180 + 10(%) drop out = 180 + 180/ (1-0.1)2 = 222.2 Total 220 subjects', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to14 days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lacidofil Capsule Versus Placebo Drug', 'description': 'Lacidofil capsule: Lactobacillus rhamnosus R0011‧Lactobacillus acidophilus R0052 bacterial culture (2x109), maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) Placebo drug: maltodextrin, Mg stearate, ascorbic acid\n\n(1 capsule twice a day for 14 days)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '214'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '172'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Administration of contraindicated drugs', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'From September 2008 to November 2009, medical clinic', 'preAssignmentDetails': 'Patients who begin receiving antibiotics prior to 48 hours before enrollment in this study'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Lacidofil Capsule Versus Placebo Drug', 'description': 'Lacidofil capsule: Lactobacillus rhamnosus R0011‧Lactobacillus acidophilus R0052 bacterial culture (2x109), maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) Placebo drug: maltodextrin, Mg stearate, ascorbic acid\n\n(1 capsule twice a day for 14 days)'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '112', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '102', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.5', 'spread': '15.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '82', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '132', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '214', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 214}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-04-15', 'studyFirstSubmitDate': '2010-01-26', 'resultsFirstSubmitDate': '2010-03-08', 'studyFirstSubmitQcDate': '2010-01-27', 'lastUpdatePostDateStruct': {'date': '2010-04-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-03-08', 'studyFirstPostDateStruct': {'date': '2010-01-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of AAD', 'timeFrame': 'Up to 14 days', 'description': 'AAD defined as: Watery stools more than 3 times per day for at least 2 days.'}], 'secondaryOutcomes': [{'measure': 'Presence of Bowel Habit Change (Watery Stools More Than 2 Times Per Day for at Least 2 Days)', 'timeFrame': 'Up to14 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['antibiotics associated colitis', 'lactobacilli', 'probiotics', 'prevention', 'pulmonary infection', 'Prevention of antibiotics associated colitis', 'the role of probiotics for prevention of antibiotics associated colitis', 'the lactobacilli effect for antibiotics associated colitis', 'antibiotic associated colitis on pulmonary infectious disease'], 'conditions': ['Antibiotics Associated Colitis', 'Pulmonary Infection']}, 'descriptionModule': {'briefSummary': 'Antibiotic-Associated Diarrhea (AAD) is a common complication of antibiotic use. The frequency of AAD can be high (26 - 60%) or moderate (13-29%) during hospital outbreaks and is relatively infrequent in outpatients. The risk factors for AAD include broad-spectrum antibiotics, host factors (age, health status, and gender), hospitalization period and exposure to nosocomial pathogens. AAD occurs 2-8 weeks after exposure to antibiotics as a result of disrupting normal intestinal microflora. One of the roles of normal intestinal microflora is to act as a protective barrier that resists the colonization of intestinal pathogens. These patients are susceptible to infection by opportunistic pathogens without this protective barrier. Probiotic therapy is suited to AAD and Clostridium difficile disease. Probiotics assist in reestablishing the disrupted intestinal microflora, enhancing immune responses and clearing pathogens and their toxins from the host. Studies using probiotics have been reported for the past twenty-eight years (1977\\~2005), but the studies have been variable in trial designs and types of probiotics, had differing doses and durations of treatment, and thus have yielded controversial results. The investigators will conduct a multi-center, randomized, placebo-controlled, double-blind trial to assess the efficacy of the probiotic Lactobacilli (Lacidofil cap®) for the prevention of AAD in adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with respiratory tract infection who begin receiving antibiotic therapy (both hospitalized patients and out-patients)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female over 18\n* Patients with respiratory tract infection who are receiving an oral or injection antibiotics.\n* Signed informed consent form prior to inclusion in the study.\n* Patients who begin receiving antibiotics within 48 hours before enrollment in this study.\n\nExclusion Criteria:\n\n* Diagnosed Clostridium difficile colitis within the last 3 months\n* Patients with tube feeding, ileostomy or colostomy\n* Patients with basal diarrheal disease; acute enteritis, chronic diarrhea such as inflammatory bowel disease (IBD) etc, radiation enteritis, ischemic colitis and diarrhea caused by carcinoids etc.\n* Patients receiving other probiotics during the last 15 days\n* Patients treated with immunosuppressant drugs or immune deficiency patients\n* Patients with radiotherapy and chemotherapy treatment for cancer.\n* Patients treated with antidiarrheal, antispasmodic or motility agents for other diseases.\n* Pregnant/Lactating women\n* Patients with gastrointestinal (GI) surgery during the last 3 months.\n* A history of hypersensitivity to cephalosporins, penicillin or clavulanic acid.\n* Patients with verified diabetic autonomic neuropathy.\n* Patients with organ transplants.\n* Patients with underlying conditions or diseases which, in the opinion of the investigator, are unsuitable for inclusion.'}, 'identificationModule': {'nctId': 'NCT01058356', 'briefTitle': 'Effect of Probiotic Lactobacilli (Lacidofil Cap®) for the Prevention of Antibiotic-Associated Diarrhea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pharmbio Korea Co., Ltd.'}, 'officialTitle': 'Effect of Probiotic Lactobacilli (Lacidofil Cap®) for the Prevention of Antibiotic-Associated Diarrhea: Prospective, Randomized Double-blind, Multicenter Study', 'orgStudyIdInfo': {'id': 'KASID_lacidofil_1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IBD research group in KASID', 'description': 'KASID is Korean Association Study of Intestinal Disease. It has several research group suh as inflammatory bowel disease (IBD) research group.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-280', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'KASID IBD Research Group', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Sung-Ae Jung, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ewha Womans University Mokdong Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pharmbio Korea Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'NAM, Bong kil/ CEO & President', 'oldOrganization': 'Pharmbio Korea'}}}}