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Clinical trial

Bacteriotherapy to Improve Underarm Odor

ID
Name
CMET
Description
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.
Trial arms
Trial start
2018-10-01
Estimated PCD
2022-12-30
Trial end
2022-12-30
Status
Completed
Phase
Early phase I
Treatment
Bacterial spray
Bacterial spray containing bacteria that do not cause underarm malodor
Arms:
Placebo arm, Treatment arm
Size
67
Primary endpoint
Improved underarm odor
1 month
Eligibility criteria
Inclusion Criteria: * above average underarm malodor * microbiome dominated with malodorous bacteria Exclusion Criteria: * not healthy * microbiome with too high levels of Staphylococcus
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'two groups of 30 people, one month of bacterial spray use and the other month placebo.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Double blind: participants nor outcome assessors, odor panel or care providers do not know which spray they use.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 67, 'type': 'ACTUAL'}}
Updated at
2023-12-15

1 organization

1 product

1 indication

Organization
Ghent University
Product
Bacterial spray
Indication
Bromhidrosis