Microbial Community Transplantation on the Armpit.

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

The malodour generation of a person's armpit is caused by the bacteria thriving on that armpit. In order to alter or reduce once bad body odour, the living microbial community on the armpit of a non-malodorous person will be transmitted (or up scaled and transmitted) to the armpit of a malodorous person. The odour is evaluated by a trained smelling panel, the bacteria living on the armpit is examined by means of molecular techniques. The microbial transplantation and its follow-up happens under the supervision of a medical doctor.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Ghent University Hospital
  • Ghent, Belgium, 9000
    • Ghent University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• bad armpit odour

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: heavy armpit odour; subjects with heavy armpit odour	Biological: Microbial transplant; Every subject has 2 armpits; 1 armpit is treated, the other one is not treated. There is a microbial transplant from armpit bacteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of bad odour of the armpit.	Odour evaluation by a trained smelling panel. The measurements take place before (once), during the treatment week (5 times) and after the treatment (2x per week during 2 months).	24 evaluations in approximately 10 weeks.
Molecular characterisation of the bacterial community after microbial transplantation.	Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis. The measurements take place before (once), during the treatment week (5 times) and after the treatment (2x per week during 2 months).	24 evaluations in approximately 10 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of bad odour of the armpit over a longer period.	Odour evaluation by a trained smelling panel.	after 4 months
Reduction of bad odour of the armpit over a longer period.	Odour evaluation by a trained smelling panel.	after 6 months
Molecular characterisation of the bacterial community after microbial transplantation.	Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis.	after 4 months
Molecular characterisation of the bacterial community after microbial transplantation.	Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis.	After 6 months

Collaborators and Investigators

• Sponsor: University Ghent
• Collaborators: University Hospital, Ghent
• Investigators: Study Chair: Nico Boon, PhD, University Ghent

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2013
• Primary Completion (ACTUAL): June 1, 2015
• Study Completion (ACTUAL): August 1, 2015

Study Registration Dates

• First Submitted: September 12, 2013
• First Submitted That Met QC Criteria: September 12, 2013
• First Posted (ESTIMATE): September 17, 2013

Study Record Updates

• Last Update Posted (ACTUAL): December 2, 2021
• Last Update Submitted That Met QC Criteria: November 19, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2013/681