Microbial Community Transplantation on the Armpit/Foot - Full Text View

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:

MedlinePlus related topics: Foot Health

U.S. FDA Resources

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).

Estimated Enrollment:	20
Study Start Date:	September 2012
Estimated Study Completion Date:	June 2013
Estimated 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

Contacts

Contact: Chris Callewaert

chris.callewaert@ugent.be

Locations

Belgium
Ghent University	Not yet recruiting
Ghent, Belgium
Contact: Nico Boon, MD, PhD nico.boon@ugent.be
Principal Investigator: Nico Boon, MD, PhD
Sub-Investigator: Chris Callewaert

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:	April 18, 2012
Health Authority:	Belgium: Ethics Committee

ClinicalTrials.gov processed this record on May 19, 2013