Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 3:58 PM
Study NCT ID:
NCT01609660
Status:
COMPLETED
Last Update Posted:
2016-09-12
First Post:
2012-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Probiotics on the Intestinal Microbiota
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-09', 'studyFirstSubmitDate': '2012-05-27', 'studyFirstSubmitQcDate': '2012-05-31', 'lastUpdatePostDateStruct': {'date': '2016-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mucosal cytokine', 'timeFrame': 'April 2013', 'description': 'To assess mucosal cytokine levels'}], 'secondaryOutcomes': [{'measure': 'Short chain fatty acids', 'timeFrame': 'April 2013', 'description': 'Assess mucosal short chain fatty acids'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['probiotics', 'cytokine', 'short chain fatty acids', 'complications', 'colorectal surgery'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the impact of probiotic administration (Saccharomyces boulardii) on patients undergoing colorectal resections comparing to the routine protocol by assessing: (1)intestinal microbiota modulation using RT-PCR to measure cytokine in the mucosa; (2) assess postoperative complications, mainly infectious and mortality, as well as length of hospital stay', 'detailedDescription': 'The intestinal microbiota, a complex and dynamic population of different bacterial species, under normal circumstances, represents an important contribution to the health of the host. This plays a key role by maintaining the integrity of the epithelial barrier and helping the development of mucosal immunity. However, under some stressful situations, such as after gastrointestinal surgery, infectious complications may be originated from the patient\'s own intestinal microbiota. This leads to the so called "gut origin of sepsis" hypothesis. On the other hand, under similar conditions, the supply of probiotics, the good bacteria, has been shown to be beneficial, despite few controversial results. Therefore, it is important to carefully assess the efficacy of probiotics in the prevention and treatment of complications in surgical patients, as well as to evaluate the safety of its use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* older than 18 years old\n* intend to undergo elective colon resection at the UFMG Hospital\n\nExclusion Criteria:\n\n* Patients in use of steroids\n* Patients unable to receive the probiotics for, at least, 7 days before the operation\n* Changes to the operation strategy\n* Patients that discontinued probiotic use\n* Patients who had previously taken any probiotic or prebiotic'}, 'identificationModule': {'nctId': 'NCT01609660', 'briefTitle': 'Impact of Probiotics on the Intestinal Microbiota', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Minas Gerais'}, 'officialTitle': 'Impact of Probiotics on the Intestinal Microbiota and Its Association With Postoperative Outcome After Colorectal Surgery', 'orgStudyIdInfo': {'id': 'CDS - APQ-01005-11'}, 'secondaryIdInfos': [{'id': 'CDS - APQ-01005-11', 'type': 'OTHER_GRANT', 'domain': 'FAPEMIG - CDS - APQ-01005-11'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'No intervention at all'}, {'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'Use of Saccharomyces boulardii, 100mg for at least seven days before surgery', 'interventionNames': ['Dietary Supplement: Saccharomyces boulardii']}], 'interventions': [{'name': 'Saccharomyces boulardii', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Floratil'], 'description': '100mg daily for seven days prior to surgery', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Maria Isabel Correia, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UFMG'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Scientific publications'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Minas Gerais', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery, responsible investigator', 'investigatorFullName': 'Maria Isabel Toulson Davisson Correia', 'investigatorAffiliation': 'Federal University of Minas Gerais'}}}}