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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014