Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-04-29 @ 2:09 PM
Study NCT ID:
NCT02722993
Status:
COMPLETED
Last Update Posted:
2018-09-26
First Post:
2016-03-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of a Probiotic Product in Children With Antibiotic-associated Gastrointestinal Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-24', 'studyFirstSubmitDate': '2016-03-16', 'studyFirstSubmitQcDate': '2016-03-23', 'lastUpdatePostDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of loose/watery stools', 'timeFrame': '19-26 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Antibiotic-associated Diarrhea']}, 'descriptionModule': {'briefSummary': 'To assess the effect of a probiotic product, when co-administered with antibiotics, on gastrointestinal symptoms following antibiotic treatment in children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children at the age of 1-11 years that have been prescribed antibiotic treatment.\n* Problems with loose stools during earlier antibiotic treatments.\n* Children whose parents or legal caregivers have signed the informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Chronic intestinal disease, immunodeficiency or immunosuppressive treatment.\n* Chronic or acute diarrheal disease.\n* Use of laxatives the week before inclusion in the study.\n* Antibiotic treatment for the last four weeks before inclusion in the study.\n* Intake of probiotic products for the last two weeks before inclusion in the study.\n* Known hypersensitivity to any of the ingredients in the probiotic product or the placebo (potato starch ± bacterial culture that may contain traces of soy).\n* Patient requiring hospitalisation.'}, 'identificationModule': {'nctId': 'NCT02722993', 'briefTitle': 'Efficacy of a Probiotic Product in Children With Antibiotic-associated Gastrointestinal Disorders', 'organization': {'class': 'INDUSTRY', 'fullName': 'Probi AB'}, 'orgStudyIdInfo': {'id': 'ProGastro Kids 16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Probiotics', 'interventionNames': ['Dietary Supplement: Probiotics']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Probiotics', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Probiotics']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Warsaw', 'country': 'Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Piotr Socha, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Memorial Health Institute, Warzaw, Poland"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Probi AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}