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Microbial Community Transplantation on the Armpit/Foot

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01581112
Recruitment Status : Completed
First Posted : April 19, 2012
Last Update Posted : September 18, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Heavy, Bad Body Odour From Armpit Heavy, Bad Body Odour From Foot Biological: Microbial transplant

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Microbial Community Transplantation on the Armpit/Foot in Order to Reduce the Malodour Generation on Armpit/Foot
Study Start Date : September 2012
Primary Completion Date : May 2013
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Heavy armpit odour
Subjects with heavy armpit odour.
Biological: Microbial transplant
Every subjects has 2 armpits and 2 feet. One armpit/foot is treated, the other is not treated.
Experimental: Heavy foot odour
Subjects with heavy foot odour.
Biological: Microbial transplant
Every subjects has 2 armpits and 2 feet. One armpit/foot is treated, the other is not treated.


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Bad armpit or foot odour
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01581112


Locations
Belgium
Ghent University
Ghent, Belgium
Sponsors and Collaborators
University Ghent
Investigators
Principal Investigator: Jo Lambert, MD, PhD University Hospital, Ghent
More Information

Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT01581112     History of Changes
Other Study ID Numbers: 2012/256
First Posted: April 19, 2012    Key Record Dates
Last Update Posted: September 18, 2013
Last Verified: September 2013