Clinical trial NCT01581112: Microbial Community Transplantation on the Armpit/Foot
Official title: Microbial Community Transplantation on the Armpit/Foot in Order to Reduce the Malodour Generation on Armpit/Foot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heavy, Bad Body Odour From Armpit
Heavy, Bad Body Odour From Foot
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2012-04-19
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The malodour generation of a person's armpit/foot is caused by the bacteria thriving on that armpit/foot. In order to alter or reduce once bad body odour or foot odour, the living microbial community on the foot/armpit of a non-malodorous person will be transmitted (or up scaled and transmitted) to the foot/armpit of a malodorous person. The odour is evaluated by a trained smelling panel, the bacteria living on the armpit/foot is examined by means of molecular techniques. The microbial transplantation and its follow-up happens under the supervision of a doctor.


Eligibility criteria: Inclusion Criteria:

* Bad armpit or foot odour

Primary outcomes:
measure: Change in odour severity after bacterial transplantation
timeFrame: Baseline and day 1
measure: Change in odour severity after bacterial transplantation
timeFrame: Baseline and day 2
measure: Change in odour severity after bacterial transplantation
timeFrame: Baseline and day 3
measure: Change in odour severity after bacterial transplantation
timeFrame: Baseline and day 4
measure: Change in odour severity after bacterial transplantation
timeFrame: Baseline and day 5
measure: Change in odour severity after bacterial transplantation
timeFrame: Baseline and week 2
measure: Change in odour severity after bacterial transplantation
timeFrame: Baseline and week 3
measure: Change in odour severity after bacterial transplantation
timeFrame: Baseline and week 4
measure: Change in molecular characterisation of the bacterial community.
timeFrame: Baseline and day 1
measure: Change in molecular characterisation of the bacterial community.
timeFrame: Baseline and day 2
measure: Change in molecular characterisation of the bacterial community.
timeFrame: Baseline and day 3
measure: Change in molecular characterisation of the bacterial community.
timeFrame: Baseline and day 4
measure: Change in molecular characterisation of the bacterial community.
timeFrame: Baseline and day 5
measure: Change in molecular characterisation of the bacterial community.
timeFrame: Baseline and week 2
measure: Change in molecular characterisation of the bacterial community.
timeFrame: Baseline and week 3
measure: Change in molecular characterisation of the bacterial community.
timeFrame: Baseline and week 4
Secondary outcomes:
measure: Change in odour severity after bacterial transplantation
timeFrame: Baseline and 2 months
measure: Change in odour severity after bacterial transplantation
timeFrame: Baseline and 4 months
measure: Change in odour severity after bacterial transplantation
timeFrame: Baseline and 6 months
measure: Change in molecular characterisation of the bacterial community
timeFrame: Baseline and 2 months
measure: Change in molecular characterisation of the bacterial community
timeFrame: Baseline and 4 months
measure: Change in molecular characterisation of the bacterial community
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University
Study officials:
affiliation: University Hospital, Ghent
name: Jo Lambert, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: