Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2026-04-10 @ 3:15 PM
Study NCT ID:
NCT02477033
Status:
COMPLETED
Last Update Posted:
2015-06-22
First Post:
2015-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Butyricicoccus Pullicaecorum in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C008315', 'term': 'maltodextrin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-17', 'studyFirstSubmitDate': '2015-06-12', 'studyFirstSubmitQcDate': '2015-06-17', 'lastUpdatePostDateStruct': {'date': '2015-06-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety profile of Butyricicoccus pullicaecorum intake (composite outcome measure), measured by abdominal complaints surveys, standard blood tests and fecal calprotectin measurements', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'The effect of Butyricicoccus pullicaecorum intake on gut microbiota composition, measured by 16S rDNA Illumina profiling of the bacterial communities', 'timeFrame': '1 year'}, {'measure': 'The effect of Butyricicoccus pullicaecorum intake on gut microbiota activity, measured by GC-MS analysis of the fecal volatile organic compounds', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'During this project the safety, tolerability and effect on gut microbiota of oral administration of Butyricicoccus pullicaecorum was investigated in healthy human volunteers by a placebo-controlled cross-over randomized study.', 'detailedDescription': 'Intervention periods were 4 weeks, with daily intake of 1 capsule. Wash-out periods were 3 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* BMI between 18 and 28 kg/m²\n* Good general health\n* Regular eating pattern (3 meals/day on at least 5 days/week)\n\nExclusion Criteria:\n\n* Chronic gastrointestinal disease (Crohn's disease, ulcerative colitis, irritable bowel syndrome, chronic constipation or chronic diarrhea)\n* Surgery of the gastrointestinal tract (except for an appendectomy)\n* Use of antibiotics during the month preceding the study\n* Use of medication or dietary supplements influencing gut transit or intestinal microbiota during the month preceding the study. Examples of such medication/dietary supplements are antispasmodics (e.g. buscopan), antidiarrheal medication (e.g. imodium), probiotic medication (e.g. lacteol, enterol)\n* Intake of pre- or probiotics during the study or during the month preceding the study\n* Being on a weight-loss diet during the study or during the month preceding the study\n* Extreme dietary habits (e.g. vegan, Atkins diet, Montignac diet)\n* Females who are pregnant, lactating or planning to become pregnant during the study period"}, 'identificationModule': {'nctId': 'NCT02477033', 'briefTitle': 'Impact of Butyricicoccus Pullicaecorum in Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'officialTitle': 'A Placebo-controlled Cross-over Randomized Study to Investigate the Impact of Butyricicoccus Pullicaecorum in Healthy Human Volunteers', 'orgStudyIdInfo': {'id': 'ML9449'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Butyricicoccus pullicaecorum', 'description': 'Lyophilized Butyricicoccus pullicaecorum 25-3T bacteria, encapsulated with a pH-resistent coating.', 'interventionNames': ['Dietary Supplement: Butyricicoccus pullicaecorum 25-3T']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (maltodextrin)', 'description': 'Lyophilized maltodextrin, encapsulated with a pH-resistent coating.', 'interventionNames': ['Other: Maltodextrin']}], 'interventions': [{'name': 'Butyricicoccus pullicaecorum 25-3T', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['LMG 24109T; CCUG 55265T'], 'armGroupLabels': ['Butyricicoccus pullicaecorum']}, {'name': 'Maltodextrin', 'type': 'OTHER', 'armGroupLabels': ['Placebo (maltodextrin)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams-Brabant', 'country': 'Belgium', 'facility': 'KULeuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Kristin Verbeke', 'investigatorFullName': 'Kristin Verbeke', 'investigatorAffiliation': 'KU Leuven'}}}}