Microbial Community Transplantation on the Armpit.

Heavy, Bad Odour From Armpit Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01944566
• Other study ID #: 2013/681
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: August 2015

Study information

• Verified date: November 2021
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• bad armpit odour

Related Conditions & MeSH terms

• Heavy, Bad Odour From Armpit

Intervention

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.

Locations

Country	Name	City	State
Belgium	Ghent University	Ghent
Belgium	Ghent University Hospital	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Ghent	University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

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