Microbial Community Transplantation on the Armpit.

Study Overview
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Brief Summary
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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.

Official Title
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Microbial Community Transplantation on the Armpit in Order to Reduce the Malodour Generation on Armpit.

Conditions
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Heavy, Bad Odour From Armpit

Intervention / Treatment
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* Biological: Microbial transplant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: bad armpit odour

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: heavy armpit odour<br>subjects with heavy armpit odour | Biological: Microbial transplant<br>* Every subject has 2 armpits; 1 armpit is treated, the other one is not treated. There is a microbial transplant from armpit bacteria.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of bad odour of the armpit. | 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). | 24 evaluations in approximately 10 weeks. | 
| Molecular characterisation of the bacterial community after microbial transplantation. | 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). | 24 evaluations in approximately 10 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of bad odour of the armpit over a longer period. | Odour evaluation by a trained smelling panel. | after 4 months | 
| Reduction of bad odour of the armpit over a longer period. | Odour evaluation by a trained smelling panel. | after 6 months | 
| Molecular characterisation of the bacterial community after microbial transplantation. | Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis. | after 4 months | 
| Molecular characterisation of the bacterial community after microbial transplantation. | Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis. | After 6 months |