Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-01-12 @ 2:29 PM
Study NCT ID:
NCT03134469
Status:
COMPLETED
Last Update Posted:
2018-09-25
First Post:
2017-04-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Probiotics on Excessive Gas Accumulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005414', 'term': 'Flatulence'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-10-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-24', 'studyFirstSubmitDate': '2017-04-26', 'studyFirstSubmitQcDate': '2017-04-26', 'lastUpdatePostDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Breath hydrogen', 'timeFrame': '4 hours', 'description': 'The level of breath hydrogen is measured after a challenge with lactulose'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Flatulence', 'Bloating']}, 'descriptionModule': {'briefSummary': 'Efficacy of probiotics on excessive gas accumulation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults 18-50 years, at the time of signing the informed consent.\n* Willing and able to give written informed consent for participating in the study\n* Willing to comply with all study procedures\n\nExclusion Criteria:\n\n* Chronic intestinal disease, immunodeficiency disorder or immunosuppressive treatment\n* Clinically significant frequent constipation or diarrhea at the screening visit as judged by the Investigator\n* Known gluten intolerance, lactose intolerance, milk protein allergy\n* Vegetarian diet\n* Intake of antibiotics within four weeks prior to the start of the study\n* Hypersensitivity to any of the ingredients in the investigational product (IP)\n* Regular intake of probiotics within four weeks prior to the start of the study\n* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk if participating in the study, or influence the results or the subject´s ability to participate in the study\n* Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.'}, 'identificationModule': {'nctId': 'NCT03134469', 'briefTitle': 'Efficacy of Probiotics on Excessive Gas Accumulation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Probi AB'}, 'officialTitle': 'Efficacy of Probiotics on Excessive Gas Accumulation', 'orgStudyIdInfo': {'id': 'ProGastro 17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotics', 'description': 'Intake of a probiotic capsule once daily', 'interventionNames': ['Dietary Supplement: Probiotic supplement']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Intake of a placebo capsule once daily', 'interventionNames': ['Dietary Supplement: Placebo supplement']}], 'interventions': [{'name': 'Probiotic supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Probiotic supplement', 'armGroupLabels': ['Probiotics']}, {'name': 'Placebo supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo supplement', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lund', 'country': 'Sweden', 'facility': 'Lund University', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'city': 'Uppsala', 'country': 'Sweden', 'facility': 'CTC Clinical Consultants', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Probi AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}