Microbial Community Transplantation on the Armpit/Foot

Study Overview
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Brief Summary
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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.

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

Conditions
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Heavy, Bad Body Odour From Armpit, Heavy, Bad Body Odour From Foot

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 or foot 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
Allocation: Non-Randomized
Intervention Model: Parallel 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 subjects has 2 armpits and 2 feet. One armpit/foot is treated, the other is not treated.<br>|
| Experimental: Heavy foot odour<br>Subjects with heavy foot odour. | Biological: Microbial transplant<br>* Every subjects has 2 armpits and 2 feet. One armpit/foot is treated, the other is not treated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in odour severity after bacterial transplantation | Odour evaluation by a trained smelling panel. | Baseline and day 1 | 
| Change in odour severity after bacterial transplantation | Odour evaluation by a trained smelling panel. | Baseline and day 2 | 
| Change in odour severity after bacterial transplantation | Odour evaluation by a trained smelling panel. | Baseline and day 3 | 
| Change in odour severity after bacterial transplantation | Odour evaluation by a trained smelling panel. | Baseline and day 4 | 
| Change in odour severity after bacterial transplantation | Odour evaluation by a trained smelling panel. | Baseline and day 5 | 
| Change in odour severity after bacterial transplantation | Odour evaluation by a trained smelling panel. | Baseline and week 2 | 
| Change in odour severity after bacterial transplantation | Odour evaluation by a trained smelling panel. | Baseline and week 3 | 
| Change in odour severity after bacterial transplantation | Odour evaluation by a trained smelling panel. | Baseline and week 4 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in odour severity after bacterial transplantation | Odour evaluation by a trained smelling panel. | Baseline and 2 months | 
| Change in odour severity after bacterial transplantation | Odour evaluation by a trained smelling panel. | Baseline and 4 months | 
| Change in odour severity after bacterial transplantation | Odour evaluation by a trained smelling panel. | Baseline and 6 months | 
| 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 | 
| 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 | 
| 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 |