Microbial Community Transplantation on the Armpit/Foot

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

Study Overview

• Status: Completed
• Conditions: Heavy, Bad Body Odour From Armpit; Heavy, Bad Body Odour From Foot
• Intervention / Treatment: Biological: Microbial transplant

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium
    • Ghent University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Bad armpit or foot odour

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in odour severity after bacterial transplantation	Odour evaluation by a trained smelling panel.	Baseline and day 1
Change in odour severity after bacterial transplantation	Odour evaluation by a trained smelling panel.	Baseline and day 2
Change in odour severity after bacterial transplantation	Odour evaluation by a trained smelling panel.	Baseline and day 3
Change in odour severity after bacterial transplantation	Odour evaluation by a trained smelling panel.	Baseline and day 4
Change in odour severity after bacterial transplantation	Odour evaluation by a trained smelling panel.	Baseline and day 5
Change in odour severity after bacterial transplantation	Odour evaluation by a trained smelling panel.	Baseline and week 2
Change in odour severity after bacterial transplantation	Odour evaluation by a trained smelling panel.	Baseline and week 3
Change in odour severity after bacterial transplantation	Odour evaluation by a trained smelling panel.	Baseline and week 4
Change in molecular characterisation of the bacterial community.	Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE).	Baseline and day 1
Change in molecular characterisation of the bacterial community.	Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE).	Baseline and day 2
Change in molecular characterisation of the bacterial community.	Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE).	Baseline and day 3
Change in molecular characterisation of the bacterial community.	Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE).	Baseline and day 4
Change in molecular characterisation of the bacterial community.	Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE).	Baseline and day 5
Change in molecular characterisation of the bacterial community.	Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE).	Baseline and week 2
Change in molecular characterisation of the bacterial community.	Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE).	Baseline and week 3
Change in molecular characterisation of the bacterial community.	Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE).	Baseline and week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in odour severity after bacterial transplantation	Odour evaluation by a trained smelling panel.	Baseline and 2 months
Change in odour severity after bacterial transplantation	Odour evaluation by a trained smelling panel.	Baseline and 4 months
Change in odour severity after bacterial transplantation	Odour evaluation by a trained smelling panel.	Baseline and 6 months
Change in molecular characterisation of the bacterial community	Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE).	Baseline and 2 months
Change in molecular characterisation of the bacterial community	Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE).	Baseline and 4 months
Change in molecular characterisation of the bacterial community	Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE).	Baseline and 6 months

Collaborators and Investigators

• Sponsor: University Ghent
• Investigators: Principal Investigator: Jo Lambert, MD, PhD, University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: April 18, 2012
• First Submitted That Met QC Criteria: April 18, 2012
• First Posted (Estimate): April 19, 2012

Study Record Updates

• Last Update Posted (Estimate): September 18, 2013
• Last Update Submitted That Met QC Criteria: September 17, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 2012/256