Heavy, Bad Body Odour From ArmpitNCT01581112
Microbial Community Transplantation on the Armpit/Foot
A study testing Microbial transplant in people with Heavy, Bad Body Odour From Armpit and Heavy, Bad Body Odour From Foot, run by University Ghent at 1 site in Belgium.
Trial summary
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… 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 Body Odour From Armpit, Heavy, Bad Body Odour From Foot
- What is being tested?
- Microbial transplant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2012to Jun 2013
- 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 or foot odour
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- 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 subjects has 2 armpits and 2 feet. One armpit/foot is treated, the other is not treated.
| Study group | Role | What they receive |
|---|---|---|
| Heavy armpit odour | Experimental | Subjects with heavy armpit odour. Receives: Biological: Microbial transplant |
| Heavy foot odour | Experimental | Subjects with heavy foot odour. Receives: Biological: Microbial transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in odour severity after bacterial transplantation
Odour evaluation by a trained smelling panel.
Measured: Baseline and day 1
Change in odour severity after bacterial transplantation
Odour evaluation by a trained smelling panel.
Measured: Baseline and day 2
Change in odour severity after bacterial transplantation
Odour evaluation by a trained smelling panel.
Measured: Baseline and day 3
Change in odour severity after bacterial transplantation
Odour evaluation by a trained smelling panel.
Measured: Baseline and day 4
Change in odour severity after bacterial transplantation
Odour evaluation by a trained smelling panel.
Measured: Baseline and day 5
Change in odour severity after bacterial transplantation
Odour evaluation by a trained smelling panel.
Measured: Baseline and week 2
Change in odour severity after bacterial transplantation
Odour evaluation by a trained smelling panel.
Measured: Baseline and week 3
Change in odour severity after bacterial transplantation
Odour evaluation by a trained smelling panel.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline and week 4
Secondary outcomes (6)
Change in odour severity after bacterial transplantation
Odour evaluation by a trained smelling panel.
Measured: Baseline and 2 months
Change in odour severity after bacterial transplantation
Odour evaluation by a trained smelling panel.
Measured: Baseline and 4 months
Change in odour severity after bacterial transplantation
Odour evaluation by a trained smelling panel.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2012 (estimated)
- Study startSep 2012
- Primary completionMay 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heavy, Bad Body 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jo Lambert, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01581112
- Sponsor's protocol ID
- 2012/256
- Status last verified
- Sep 2013
- First submitted
- 18 Apr 2012
- Last updated
- 18 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbial Community Transplantation on the Armpit/Foot in Order to Reduce the Malodour Generation on Armpit/Foot
- ClinicalTrials.gov ID
- NCT01581112
- Acronym / sponsor ID
- 2012/256
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 19 Apr 2012 (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/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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heavy armpit odour | Experimental | Biological: Microbial transplantSubjects with heavy armpit odour. |
| Heavy foot odour | Experimental | Biological: Microbial transplantSubjects with heavy foot 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 or foot 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 subjects has 2 armpits and 2 feet. One armpit/foot is treated, the other is not treated. | Biological | Heavy armpit odour, Heavy foot odour |
Primary outcome
Change in odour severity after bacterial transplantation
Time frame: Baseline and day 1
Odour evaluation by a trained smelling panel.
Change in odour severity after bacterial transplantation
Time frame: Baseline and day 2
Odour evaluation by a trained smelling panel.
Change in odour severity after bacterial transplantation
Time frame: Baseline and day 3
Odour evaluation by a trained smelling panel.
Change in odour severity after bacterial transplantation
Time frame: Baseline and day 4
Odour evaluation by a trained smelling panel.
Change in odour severity after bacterial transplantation
Time frame: Baseline and day 5
Odour evaluation by a trained smelling panel.
Change in odour severity after bacterial transplantation
Time frame: Baseline and week 2
Odour evaluation by a trained smelling panel.
Change in odour severity after bacterial transplantation
Time frame: Baseline and week 3
Odour evaluation by a trained smelling panel.
Change in odour severity after bacterial transplantation
Time frame: Baseline and week 4
Odour evaluation by a trained smelling panel.
Change in molecular characterisation of the bacterial community.
Time frame: Baseline and day 1
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
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
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
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
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
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
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
Microbial evaluation by means of DNA extraction and Denaturing Gradient Gel Electrophoresis (DGGE).
6 secondary outcomes
Change in odour severity after bacterial transplantation
Time frame: Baseline and 2 months
Change in odour severity after bacterial transplantation
Time frame: Baseline and 4 months
Change in odour severity after bacterial transplantation
Time frame: Baseline and 6 months
Change in molecular characterisation of the bacterial community
Time frame: Baseline and 2 months
Change in molecular characterisation of the bacterial community
Time frame: Baseline and 4 months
Change in molecular characterisation of the bacterial community
Time frame: Baseline and 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 18 Sep 2013.
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.
Jo Lambert, MD, PhD principal investigator
University Hospital, Ghent
1 site 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 Body Odour From Armpit and Heavy, Bad Body Odour From Foot, run by University Ghent at 1 site 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 18 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change in odour severity after bacterial transplantation (time frame: Baseline and day 1). The study lists 16 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 18 Sep 2013.