Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-28 @ 2:55 PM
Study NCT ID:
NCT01944566
Status:
COMPLETED
Last Update Posted:
2021-12-02
First Post:
2013-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microbial Community Transplantation on the Armpit.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-19', 'studyFirstSubmitDate': '2013-09-12', 'studyFirstSubmitQcDate': '2013-09-12', 'lastUpdatePostDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of bad odour of the armpit.', 'timeFrame': '24 evaluations in approximately 10 weeks.', 'description': 'Odour evaluation by a trained smelling panel. The measurements take place before (once), during the treatment week (5 times) and after the treatment (2x per week during 2 months).'}, {'measure': 'Molecular characterisation of the bacterial community after microbial transplantation.', 'timeFrame': '24 evaluations in approximately 10 weeks.', 'description': 'Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis. The measurements take place before (once), during the treatment week (5 times) and after the treatment (2x per week during 2 months).'}], 'secondaryOutcomes': [{'measure': 'Reduction of bad odour of the armpit over a longer period.', 'timeFrame': 'after 4 months', 'description': 'Odour evaluation by a trained smelling panel.'}, {'measure': 'Reduction of bad odour of the armpit over a longer period.', 'timeFrame': 'after 6 months', 'description': 'Odour evaluation by a trained smelling panel.'}, {'measure': 'Molecular characterisation of the bacterial community after microbial transplantation.', 'timeFrame': 'after 4 months', 'description': 'Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis.'}, {'measure': 'Molecular characterisation of the bacterial community after microbial transplantation.', 'timeFrame': 'After 6 months', 'description': 'Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Heavy, Bad Odour From Armpit']}, 'descriptionModule': {'briefSummary': "The malodour generation of a person's armpit is caused by the bacteria thriving on that armpit. In order to alter or reduce once bad body odour, the living microbial community on the armpit of a non-malodorous person will be transmitted (or up scaled and transmitted) to the armpit of a malodorous person. The odour is evaluated by a trained smelling panel, the bacteria living on the armpit is examined by means of molecular techniques. The microbial transplantation and its follow-up happens under the supervision of a medical doctor."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* bad armpit odour'}, 'identificationModule': {'nctId': 'NCT01944566', 'briefTitle': 'Microbial Community Transplantation on the Armpit.', 'organization': {'class': 'OTHER', 'fullName': 'University Ghent'}, 'officialTitle': 'Microbial Community Transplantation on the Armpit in Order to Reduce the Malodour Generation on Armpit.', 'orgStudyIdInfo': {'id': '2013/681'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'heavy armpit odour', 'description': 'subjects with heavy armpit odour', 'interventionNames': ['Biological: Microbial transplant']}], 'interventions': [{'name': 'Microbial transplant', 'type': 'BIOLOGICAL', 'description': 'Every subject has 2 armpits; 1 armpit is treated, the other one is not treated. There is a microbial transplant from armpit bacteria.', 'armGroupLabels': ['heavy armpit odour']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Ghent University Hospital', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Ghent University', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Nico Boon, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Ghent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Ghent', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Ghent', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}