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Bacteriotherapy to Improve Underarm Odor

NCT ID: NCT03967470

Last Updated: 2023-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2022-12-30

Brief Summary

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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

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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

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Bromhidrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

two groups of 30 people, one month of bacterial spray use and the other month placebo.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
Double blind: participants nor outcome assessors, odor panel or care providers do not know which spray they use.

Study Groups

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Placebo arm

Placebo spray used during one month

Group Type PLACEBO_COMPARATOR

Bacterial spray

Intervention Type BIOLOGICAL

Bacterial spray containing bacteria that do not cause underarm malodor

Treatment arm

Bacteria spray used during one month

Group Type ACTIVE_COMPARATOR

Bacterial spray

Intervention Type BIOLOGICAL

Bacterial spray containing bacteria that do not cause underarm malodor

Interventions

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Bacterial spray

Bacterial spray containing bacteria that do not cause underarm malodor

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* above average underarm malodor
* microbiome dominated with malodorous bacteria

Exclusion Criteria

* not healthy
* microbiome with too high levels of Staphylococcus
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tom Van de Wiele, PhD

Role: STUDY_CHAIR

University Ghent

Locations

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Ghent University

Ghent, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type RESULT
PMID: 27892611 (View on PubMed)

Related Links

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http://www.drarmpit.com

Related Info

Other Identifiers

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CMET

Identifier Type: -

Identifier Source: org_study_id