BromhidrosisPhase 2NCT03967470
Bacteriotherapy to Improve Underarm Odor
A Phase 2 study testing Bacterial spray in people with Bromhidrosis, run by University Ghent at 1 site in Belgium.
Trial summary
The goal is to improve the underarm odor by changing the microbiome. The autochthonous bacterial community is replaced by a non-smelling microbiome, by daily application of bacteria in a spray. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Bromhidrosis
- What is being tested?
- Bacterial spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2018to 30 Dec 2022
- Phase
- Phase 2
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- above average underarm malodor
- microbiome dominated with malodorous bacteria
Who cannot join
- not healthy
- microbiome with too high levels of Staphylococcus
Trial locations and contacts
1 site in 1 country.
About this study
The goal is to improve the underarm odor by changing the microbiome. The autochthonous bacterial community is replaced by a non-smelling microbiome, by daily application of bacteria in a spray.
Read the detailed description
Participants are recruited and selected based on their initial underarm odor and underarm microbiome. The participants use two sprays: one spray containing the bacteria, and the other nothing (placebo). Participants do not know which spray they have. They use one spray during one month, and meanwhile take samples of their underarm microbiome (for sequencing), volatome (for GC/MS analysis) and odor (for odor panel analysis). Samples are stored in the freezer and brought to the university after one month, when they receive the second spray. The bacterial spray contains bacteria that are correlated with good underarm odor.
- Conditions
- Bromhidrosis
- Being tested
- Bacterial spray
- Medical subject headings
- Body Odor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacterial sprayBiological
Bacterial spray containing bacteria that do not cause underarm malodor
| Study group | Role | What they receive |
|---|---|---|
| Placebo arm | Placebo comparator | Placebo spray used during one month Receives: Biological: Bacterial spray |
| Treatment arm | Active comparator | Bacteria spray used during one month Receives: Biological: Bacterial spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved underarm odor
Odor panel and GC/MS results provide insights on underarm odor development
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start1 Oct 2018
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BromhidrosisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- two groups of 30 people, one month of bacterial spray use and the other month placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tom Van de Wiele, PhD, Study chair, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967470
- Sponsor's protocol ID
- CMET
- Status last verified
- Dec 2023
- First submitted
- 27 May 2019
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data remain confidential
Publications
Callewaert C, Lambert J, Van de Wiele T. Towards a bacterial treatment for armpit malodour. Exp Dermatol. 2017 May;26(5):388-391. doi: 10.1111/exd.13259. Epub 2017 Feb 2.
PubMed 27892611
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacteriotherapy to Improve Underarm Odor
- ClinicalTrials.gov ID
- NCT03967470
- Acronym / sponsor ID
- CMET
- Conditions
- Bromhidrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 30 May 2019 (actual)
- 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 goal is to improve the underarm odor by changing the microbiome. The autochthonous bacterial community is replaced by a non-smelling microbiome, by daily application of bacteria in a spray.
Detailed description
Participants are recruited and selected based on their initial underarm odor and underarm microbiome. The participants use two sprays: one spray containing the bacteria, and the other nothing (placebo). Participants do not know which spray they have. They use one spray during one month, and meanwhile take samples of their underarm microbiome (for sequencing), volatome (for GC/MS analysis) and odor (for odor panel analysis). Samples are stored in the freezer and brought to the university after one month, when they receive the second spray. The bacterial spray contains bacteria that are correlated with good underarm odor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- two groups of 30 people, one month of bacterial spray use and the other month placebo.
| Arm | Type | Receives |
|---|---|---|
| Placebo arm | Placebo comparator | Biological: Bacterial sprayPlacebo spray used during one month |
| Treatment arm | Active comparator | Biological: Bacterial sprayBacteria spray used during one month |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- above average underarm malodor
- microbiome dominated with malodorous bacteria
Key exclusion criteria (2 listed)
- not healthy
- microbiome with too high levels of Staphylococcus
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 |
|---|---|---|
| Bacterial sprayBacterial spray containing bacteria that do not cause underarm malodor | Biological | Placebo arm, Treatment arm |
Primary outcome
Improved underarm odor
Time frame: 1 month
Odor panel and GC/MS results provide insights on underarm odor development
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 15 Dec 2023.
- Results publication: PubMed 27892611Callewaert C, Lambert J, Van de Wiele T. Towards a bacterial treatment for armpit malodour. Exp Dermatol. 2017 May;26(5):388-391. doi: 10.1111/exd.13259. Epub 2017 Feb 2.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. All data remain confidential
Related trials for Bromhidrosis
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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.
Tom Van de Wiele, PhD study chair
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bacterial spray in people with Bromhidrosis, 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 2 inclusion and 2 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 15 Dec 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Improved underarm odor (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03967470, which also lists 1 linked publication.
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 15 Dec 2023.