Bacteriotherapy to Improve Underarm Odor

University Ghent

Status and phase: Completed; Phase 2

Conditions: Bromhidrosis

Treatments: Biological: Bacterial spray

Study type: Interventional

Funder types: Other

Identifiers

NCT03967470

CMET

Details and patient eligibility

About

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.

Full 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.

Enrollment: 67 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• above average underarm malodor
• microbiome dominated with malodorous bacteria

Exclusion criteria

• not healthy
• microbiome with too high levels of Staphylococcus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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67 participants in 2 patient groups, including a placebo group

Placebo arm

Placebo Comparator group

Description:

Placebo spray used during one month

Treatment:

Biological: Bacterial spray

Treatment arm

Active Comparator group

Description:

Bacteria spray used during one month

Treatment:

Biological: Bacterial spray