Heavy, Bad Body Odour From Armpit Clinical Trial
Official title:
Microbial Community Transplantation on the Armpit/Foot in Order to Reduce the Malodour Generation on Armpit/Foot
| Verified date | September 2013 |
| Source | University Ghent |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Belgium: Ethics Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 4 |
| Est. completion date | June 2013 |
| Est. primary completion date | May 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Bad armpit or foot odour |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Ghent University | Ghent |
| Lead Sponsor | Collaborator |
|---|---|
| University Ghent |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in odour severity after bacterial transplantation | Odour evaluation by a trained smelling panel. | Baseline and day 1 | Yes |
| Primary | Change in odour severity after bacterial transplantation | Odour evaluation by a trained smelling panel. | Baseline and day 2 | Yes |
| Primary | Change in odour severity after bacterial transplantation | Odour evaluation by a trained smelling panel. | Baseline and day 3 | Yes |
| Primary | Change in odour severity after bacterial transplantation | Odour evaluation by a trained smelling panel. | Baseline and day 4 | Yes |
| Primary | Change in odour severity after bacterial transplantation | Odour evaluation by a trained smelling panel. | Baseline and day 5 | Yes |
| Primary | Change in odour severity after bacterial transplantation | Odour evaluation by a trained smelling panel. | Baseline and week 2 | Yes |
| Primary | Change in odour severity after bacterial transplantation | Odour evaluation by a trained smelling panel. | Baseline and week 3 | Yes |
| Primary | Change in odour severity after bacterial transplantation | Odour evaluation by a trained smelling panel. | Baseline and week 4 | Yes |
| Primary | Change in molecular characterisation of the bacterial community. | Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE). | Baseline and day 1 | Yes |
| Primary | Change in molecular characterisation of the bacterial community. | Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE). | Baseline and day 2 | Yes |
| Primary | Change in molecular characterisation of the bacterial community. | Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE). | Baseline and day 3 | Yes |
| Primary | Change in molecular characterisation of the bacterial community. | Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE). | Baseline and day 4 | Yes |
| Primary | Change in molecular characterisation of the bacterial community. | Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE). | Baseline and day 5 | Yes |
| Primary | Change in molecular characterisation of the bacterial community. | Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE). | Baseline and week 2 | Yes |
| Primary | Change in molecular characterisation of the bacterial community. | Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE). | Baseline and week 3 | Yes |
| Primary | Change in molecular characterisation of the bacterial community. | Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE). | Baseline and week 4 | Yes |
| Secondary | Change in odour severity after bacterial transplantation | Odour evaluation by a trained smelling panel. | Baseline and 2 months | Yes |
| Secondary | Change in odour severity after bacterial transplantation | Odour evaluation by a trained smelling panel. | Baseline and 4 months | Yes |
| Secondary | Change in odour severity after bacterial transplantation | Odour evaluation by a trained smelling panel. | Baseline and 6 months | Yes |
| Secondary | Change in molecular characterisation of the bacterial community | Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE). | Baseline and 2 months | Yes |
| Secondary | Change in molecular characterisation of the bacterial community | Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE). | Baseline and 4 months | Yes |
| Secondary | Change in molecular characterisation of the bacterial community | Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE). | Baseline and 6 months | Yes |