Microbiota
Conditions
Interventions
This is a randomized, parallel, three-arm, single-blind clinical study. A total of 81 healthy adult women, with regular menstrual cycles, and who meet the eligibility criteria will be enrolled. Partic
Sponsors
Kimberly-Clark Brasil Industria e Comercio De Produtos De Higiene Ltda
Kimberly-Clark Brasil Industria e Comercio De Produtos De Higiene Ltda
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Females; 18 to 45 years old; in good general health, with regular monthly menstrual cycles who are not expected to menstruate during the study; participants with healthy and intact skin in the test areas; and be willing to comply with study requirements
Exclusion criteria
Exclusion criteria: Participants who are pregnant or intending to become pregnant during the study; history of chronic or currently active gynecological pathologies or urogenital infections in the last 3 months; used systemic and/or topical antibiotics, antifungals, and/or corticosteroids within 4 weeks prior to visit 1 and throughout the study; any other medical condition or history that may compromise the study results or the subject’s safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to evaluate the change on Lactobacillus species abundance from baseline based genetic sequencing (16S rDNA) after 4 and 7 days wearing treated pantyliners compared to the control pantyliner | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to evaluate the safety of the pantyliners through adverse events assessment;It is expected to evaluate whether there is a difference on Lactobacillus abundance based on genetic sequencing (16S rDNA) before and after using the treated and untreated pantyliners;It is expected to evaluate the change from baseline on Lactobacillus species abundance based on genetic sequencing (16S rDNA) after 4 and 7 days wearing the treated pantyliners among each other;It is expected to evaluate whether there is a difference on the abundance of others urogenital microbial communities based on genetic sequencing (16S rDNA) before and after using the treated and untreated pantyliners;Various biophysical measurements taken in the intimate area will also be evaluated between (and among) the randomized groups and the control group at 4 and 7 days;It is expected to evaluate the self-perception of the subjects about the pantyliners with prebiotic and the control pantyliner during the study, after 7 days of product use, based on questionnaires | — |
Countries
Brazil
Contacts
Public ContactJéssica Pereira
Kimberly-Clark Brasil Industria e Comercio De Produtos De Higiene Ltda
Outcome results
None listed