Bacteriotherapy to Improve Underarm Odor

Bromhidrosis Clinical Trial

Official title:

Bacteriotherapy to Improve Underarm Odor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03967470
• Other study ID #: CMET
• Status: Completed
• Phase: Phase 2
• Start date: October 1, 2018
• Est. completion date: December 30, 2022

Study information

• Verified date: December 2023
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• above average underarm malodor

• microbiome dominated with malodorous bacteria

Exclusion Criteria:

• not healthy

• microbiome with too high levels of Staphylococcus

Related Conditions & MeSH terms

• Bromhidrosis

Intervention

Biological:
• Bacterial spray
Bacterial spray containing bacteria that do not cause underarm malodor

Locations

Country	Name	City	State
Belgium	Ghent University	Gent

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved underarm odor	Odor panel and GC/MS results provide insights on underarm odor development	1 month

External Links

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