Heavy, Bad Odour From ArmpitNCT01944566
Microbial Community Transplantation on the Armpit.
A study testing Microbial transplant in people with Heavy, Bad Odour From Armpit, run by University Ghent at 2 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Heavy, Bad Odour From Armpit
- What is being tested?
- Microbial transplant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesBelgium
- Study dates
- Oct 2013to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- bad armpit odour
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Ghent University Hospital
Ghent, 9000
Ghent University
Ghent, 9000
About this study
Official title: 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.
- Conditions
- Heavy, Bad Odour From Armpit
- Being tested
- Microbial transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbial transplantBiological
Every subject has 2 armpits; 1 armpit is treated, the other one is not treated. There is a microbial transplant from armpit bacteria.
| Study group | Role | What they receive |
|---|---|---|
| heavy armpit odour | Experimental | subjects with heavy armpit odour Receives: Biological: Microbial transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 24 evaluations in approximately 10 weeks.
Secondary outcomes (4)
Reduction of bad odour of the armpit over a longer period.
Odour evaluation by a trained smelling panel.
Measured: after 4 months
Reduction of bad odour of the armpit over a longer period.
Odour evaluation by a trained smelling panel.
Measured: after 6 months
Molecular characterisation of the bacterial community after microbial transplantation.
Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis.
Measured: after 4 months
Molecular characterisation of the bacterial community after microbial transplantation.
Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis.
Measured: After 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionJun 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heavy, Bad Odour From ArmpitStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Ghent
- Responsible party
- Sponsor
- Investigators
- Nico Boon, PhD, Study chair, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01944566
- Sponsor's protocol ID
- 2013/681
- Status last verified
- Nov 2021
- First submitted
- 12 Sep 2013
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbial Community Transplantation on the Armpit in Order to Reduce the Malodour Generation on Armpit.
- ClinicalTrials.gov ID
- NCT01944566
- Acronym / sponsor ID
- 2013/681
- Conditions
- Heavy, Bad Odour From Armpit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- University Hospital, Ghent
- Study start
- Oct 2013 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 17 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| heavy armpit odour | Experimental | Biological: Microbial transplantsubjects with heavy armpit odour |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- bad armpit odour
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microbial transplantEvery subject has 2 armpits; 1 armpit is treated, the other one is not treated. There is a microbial transplant from armpit bacteria. | Biological | heavy armpit odour |
Primary outcome
Reduction of bad odour of the armpit.
Time frame: 24 evaluations in approximately 10 weeks.
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).
Molecular characterisation of the bacterial community after microbial transplantation.
Time frame: 24 evaluations in approximately 10 weeks.
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).
4 secondary outcomes
Reduction of bad odour of the armpit over a longer period.
Time frame: after 4 months
Reduction of bad odour of the armpit over a longer period.
Time frame: after 6 months
Molecular characterisation of the bacterial community after microbial transplantation.
Time frame: after 4 months
Molecular characterisation of the bacterial community after microbial transplantation.
Time frame: After 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nico Boon, PhD study chair
University Ghent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microbial transplant in people with Heavy, Bad Odour From Armpit, run by University Ghent at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of bad odour of the armpit. (time frame: 24 evaluations in approximately 10 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2021; AzTrials last refreshed its copy on 3 Nov 2026.