Microbial Community Transplantation on the Armpit/Foot

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Ghent
ClinicalTrials.gov Identifier:
NCT01581112
First received: April 18, 2012
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

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 Intervention
Heavy, Bad Body Odour From Armpit
Heavy, Bad Body Odour From Foot
Biological: Microbial transplant

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Microbial Community Transplantation on the Armpit/Foot in Order to Reduce the Malodour Generation on Armpit/Foot

Resource links provided by NLM:


Further study details as provided by University Ghent:

Primary Outcome Measures:
  • Change in odour severity after bacterial transplantation [ Time Frame: Baseline and day 1 ] [ Designated as safety issue: Yes ]
    Odour evaluation by a trained smelling panel.

  • Change in odour severity after bacterial transplantation [ Time Frame: Baseline and day 2 ] [ Designated as safety issue: Yes ]
    Odour evaluation by a trained smelling panel.

  • Change in odour severity after bacterial transplantation [ Time Frame: Baseline and day 3 ] [ Designated as safety issue: Yes ]
    Odour evaluation by a trained smelling panel.

  • Change in odour severity after bacterial transplantation [ Time Frame: Baseline and day 4 ] [ Designated as safety issue: Yes ]
    Odour evaluation by a trained smelling panel.

  • Change in odour severity after bacterial transplantation [ Time Frame: Baseline and day 5 ] [ Designated as safety issue: Yes ]
    Odour evaluation by a trained smelling panel.

  • Change in odour severity after bacterial transplantation [ Time Frame: Baseline and week 2 ] [ Designated as safety issue: Yes ]
    Odour evaluation by a trained smelling panel.

  • Change in odour severity after bacterial transplantation [ Time Frame: Baseline and week 3 ] [ Designated as safety issue: Yes ]
    Odour evaluation by a trained smelling panel.

  • Change in odour severity after bacterial transplantation [ Time Frame: Baseline and week 4 ] [ Designated as safety issue: Yes ]
    Odour evaluation by a trained smelling panel.

  • Change in molecular characterisation of the bacterial community. [ Time Frame: Baseline and day 1 ] [ Designated as safety issue: Yes ]
    Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE).

  • Change in molecular characterisation of the bacterial community. [ Time Frame: Baseline and day 2 ] [ Designated as safety issue: Yes ]
    Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE).

  • Change in molecular characterisation of the bacterial community. [ Time Frame: Baseline and day 3 ] [ Designated as safety issue: Yes ]
    Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE).

  • Change in molecular characterisation of the bacterial community. [ Time Frame: Baseline and day 4 ] [ Designated as safety issue: Yes ]
    Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE).

  • Change in molecular characterisation of the bacterial community. [ Time Frame: Baseline and day 5 ] [ Designated as safety issue: Yes ]
    Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE).

  • Change in molecular characterisation of the bacterial community. [ Time Frame: Baseline and week 2 ] [ Designated as safety issue: Yes ]
    Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE).

  • Change in molecular characterisation of the bacterial community. [ Time Frame: Baseline and week 3 ] [ Designated as safety issue: Yes ]
    Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE).

  • Change in molecular characterisation of the bacterial community. [ Time Frame: Baseline and week 4 ] [ Designated as safety issue: Yes ]
    Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE).


Secondary Outcome Measures:
  • Change in odour severity after bacterial transplantation [ Time Frame: Baseline and 2 months ] [ Designated as safety issue: Yes ]
    Odour evaluation by a trained smelling panel.

  • Change in odour severity after bacterial transplantation [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: Yes ]
    Odour evaluation by a trained smelling panel.

  • Change in odour severity after bacterial transplantation [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: Yes ]
    Odour evaluation by a trained smelling panel.

  • Change in molecular characterisation of the bacterial community [ Time Frame: Baseline and 2 months ] [ Designated as safety issue: Yes ]
    Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE).

  • Change in molecular characterisation of the bacterial community [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: Yes ]
    Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE).

  • Change in molecular characterisation of the bacterial community [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: Yes ]
    Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE).


Enrollment: 4
Study Start Date: September 2012
Study Completion Date: June 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Bad armpit or foot odour
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01581112

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

No publications provided

Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT01581112     History of Changes
Other Study ID Numbers: 2012/256
Study First Received: April 18, 2012
Last Updated: September 17, 2013
Health Authority: Belgium: Ethics Committee

ClinicalTrials.gov processed this record on April 17, 2014