Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2026-02-23 @ 8:02 PM
Study NCT ID:
NCT03829358
Status:
COMPLETED
Last Update Posted:
2019-02-05
First Post:
2019-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Probiotics in Improving Quality of Life in Women With Functional Constipation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-29', 'size': 164202, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-02-01T02:15', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-07-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-03', 'studyFirstSubmitDate': '2019-02-01', 'studyFirstSubmitQcDate': '2019-02-01', 'lastUpdatePostDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in quality of life', 'timeFrame': 'Three weeks after intervention.', 'description': 'Improvement in quality of life were assessed using PAC-QOL© (Patient Assessment of Constipation - Quality of Life) questionnaire, consisting of four domains: physical discomfort, psychosocial discomfort, worries/concerns, and satisfaction.\n\n* Physical discomfort, minimum score 0, maximum score 16, lower value represents better outcome\n* Psychosocial discomfort, minimum score 0, maximum score 32, lower value represents better outcome\n* Worries/concerns, minimum score 0, maximum score 44, lower value represents better outcome\n* Satisfaction, minimum score 0, maximum score 20, higher value represents better outcome\n\nTotal score = physical discomfort + psychosocial discomfort + worries/concerns - satisfaction\n\n• Total score, minimum score -20, maximum score 92, lower value represents better outcome'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Constipation', 'Quality of Life', 'Probiotic', 'PAC-QOL'], 'conditions': ['Constipation - Functional']}, 'descriptionModule': {'briefSummary': 'This study aimed to investigate the relationship between administration of probiotics and improvement in quality of life in women with functional constipation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being declared healthy based on initial examination and the Structured Interview Questionnaire (SIQ)\n* Having the symptoms and signs of functional constipation refer to ROME IV\n* Able to communicate well\n* Able to consume 1 bottle of fermented milk each day for three weeks\n* Not using antibiotic no later than one week before supplementation\n\nExclusion Criteria:\n\n* Diagnosed with functional bowel disorder\n* Using anesthesia at least 4 weeks before treatment\n* Having a serious pathological disorder (carcinoma)\n* During healing phase of acute gastrointestinal disorders at least 4 weeks before treatment\n* Having severe heart disease\n* Taking chronic medications such as antidepressants or analgesics'}, 'identificationModule': {'nctId': 'NCT03829358', 'briefTitle': 'The Role of Probiotics in Improving Quality of Life in Women With Functional Constipation', 'organization': {'class': 'OTHER', 'fullName': 'Fakultas Kedokteran Universitas Indonesia'}, 'officialTitle': 'The Role of Probiotics in Improving Quality of Life in Women With Functional Constipation: Randomized Double-blind Controlled Trial', 'orgStudyIdInfo': {'id': 'SMART CITY #AID-497-A-1600004'}, 'secondaryIdInfos': [{'id': 'Sub Grant #IIE-00000078-UI-1', 'type': 'OTHER_GRANT', 'domain': 'USAID/SHERA - SMART CITY'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotic', 'description': 'Lactobacillus plantarum IS-10506', 'interventionNames': ['Drug: Lactobacillus plantarum IS-10506']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Lactobacillus plantarum IS-10506', 'type': 'DRUG', 'description': 'Fermented milk containing probiotic Lactobacillus plantarum IS-10506 to be consumed once daily for three weeks.', 'armGroupLabels': ['Probiotic']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Fermented milk containing placebo to be consumed once daily for three weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11440', 'city': 'Jakarta', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'Puskesmas Petamburan', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}], 'overallOfficials': [{'name': 'Hasan Maulahela, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fakultas Kedokteran Universitas Indonesia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fakultas Kedokteran Universitas Indonesia', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Agency for International Development (USAID)', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Murdani Abdullah', 'investigatorAffiliation': 'Fakultas Kedokteran Universitas Indonesia'}}}}