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Completed

NCT Number: NCT01581112

Microbial Community Transplantation on the Armpit/Foot

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University

Ghent, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Bad armpit or foot odour

Treatment and study plan

Microbial transplant

Biological

Every subjects has 2 armpits and 2 feet. One armpit/foot is treated, the other is not treated.

Primary outcomes

  1. Change in odour severity after bacterial transplantation

    Time frame: Baseline and day 1

    Odour evaluation by a trained smelling panel.

  2. Change in odour severity after bacterial transplantation

    Time frame: Baseline and day 2

    Odour evaluation by a trained smelling panel.

  3. Change in odour severity after bacterial transplantation

    Time frame: Baseline and day 3

    Odour evaluation by a trained smelling panel.

  4. Change in odour severity after bacterial transplantation

    Time frame: Baseline and day 4

    Odour evaluation by a trained smelling panel.

  5. Change in odour severity after bacterial transplantation

    Time frame: Baseline and day 5

    Odour evaluation by a trained smelling panel.

  6. Change in odour severity after bacterial transplantation

    Time frame: Baseline and week 2

    Odour evaluation by a trained smelling panel.

  7. Change in odour severity after bacterial transplantation

    Time frame: Baseline and week 3

    Odour evaluation by a trained smelling panel.

  8. Change in odour severity after bacterial transplantation

    Time frame: Baseline and week 4

    Odour evaluation by a trained smelling panel.

  9. Change in molecular characterisation of the bacterial community.

    Time frame: Baseline and day 1

    Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE).

  10. Change in molecular characterisation of the bacterial community.

    Time frame: Baseline and day 2

    Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE).

  11. Change in molecular characterisation of the bacterial community.

    Time frame: Baseline and day 3

    Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE).

  12. Change in molecular characterisation of the bacterial community.

    Time frame: Baseline and day 4

    Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE).

  13. Change in molecular characterisation of the bacterial community.

    Time frame: Baseline and day 5

    Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE).

  14. Change in molecular characterisation of the bacterial community.

    Time frame: Baseline and week 2

    Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE).

  15. Change in molecular characterisation of the bacterial community.

    Time frame: Baseline and week 3

    Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE).

  16. Change in molecular characterisation of the bacterial community.

    Time frame: Baseline and week 4

    Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE).

Secondary outcomes

  1. Change in odour severity after bacterial transplantation

    Time frame: Baseline and 2 months

    Odour evaluation by a trained smelling panel.

  2. Change in odour severity after bacterial transplantation

    Time frame: Baseline and 4 months

    Odour evaluation by a trained smelling panel.

  3. Change in odour severity after bacterial transplantation

    Time frame: Baseline and 6 months

    Odour evaluation by a trained smelling panel.

  4. Change in molecular characterisation of the bacterial community

    Time frame: Baseline and 2 months

    Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE).

  5. Change in molecular characterisation of the bacterial community

    Time frame: Baseline and 4 months

    Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE).

  6. Change in molecular characterisation of the bacterial community

    Time frame: Baseline and 6 months

    Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE).

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 19, 2012
Registry last updated
Sep 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.