Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-30 @ 10:42 AM
Study NCT ID:
NCT05451433
Status:
UNKNOWN
Last Update Posted:
2022-07-20
First Post:
2022-06-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Saccharomyces Boulardii in Clinical Presentation and Quality of Life Patient With IBS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Double blind randomized control trial'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-18', 'studyFirstSubmitDate': '2022-06-22', 'studyFirstSubmitQcDate': '2022-07-05', 'lastUpdatePostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical improvement quality of life within 29 days', 'timeFrame': '29 days', 'description': 'Measuring quality of life using questionnaire IBS-QOL from 0-100, the higher the score, the better the outcome.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Irritable Bowel Syndrome']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the effectiveness of Saccharomyces Boulardii vs Placebo in patient with Irritable Bowel Syndrome', 'detailedDescription': 'This study aims to compare the effectiveness of Saccharomyces Boulardii vs Placebo in patient with Irritable Bowel Syndrome within timeframe of study 28 days and then will be examined the outcome as the improvement quality of life'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criterias:\n\n* 18 years or older\n* diagnosed with IBS based on ROME IV criteria\n* agree to be participant by signing inform consent\n\nExclusion Criteria:\n\n* patient who does not want to sign the inform consent'}, 'identificationModule': {'nctId': 'NCT05451433', 'briefTitle': 'The Effect of Saccharomyces Boulardii in Clinical Presentation and Quality of Life Patient With IBS', 'organization': {'class': 'OTHER', 'fullName': 'Fakultas Kedokteran Universitas Indonesia'}, 'officialTitle': 'The Effect of Saccharomyces Boulardii in Clinical Presentation and Quality of Life Patient With IBS', 'orgStudyIdInfo': {'id': '22-03-0280'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Get intervention drug Normagut capsule twice a day', 'interventionNames': ['Drug: Saccharomyces Boulardii 250 MG']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Get placebo capsule twice a day', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Saccharomyces Boulardii 250 MG', 'type': 'DRUG', 'otherNames': ['Normagut'], 'description': 'Normagut capsule twice a day', 'armGroupLabels': ['Intervention Group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo capsule twice a day', 'armGroupLabels': ['Control Group']}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fakultas Kedokteran Universitas Indonesia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Marcellus Simadibrata, Prof. PhD., SpPD, KGEH', 'investigatorAffiliation': 'Fakultas Kedokteran Universitas Indonesia'}}}}