Effects of over-the-counter lactic acid-containing vaginal douching products on the vaginal microbiota

Completed

Conditions: seksuele gezondheid
Bacteriële vaginose
disbalance of the vaginal microbiota
10004018

Registration Number: NL-OMON41739

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 25

Inclusion Criteria

Women of reproductive age between 18-36 years

Exclusion Criteria

Pregnancy or pregnancy wish
STI diagnosis
Age <18 and >36 years
Irregular menstruation
Use of antibiotics in the last 30 days
Known gynaecological pathology

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>For each participant, the vaginal microbiota composition before initiation of<br /><br>product use, during product use, and after cessation of product use will be<br /><br>assessed by next generation sequencing.<br /><br>For a general overview of the fluctuations in the composition of the vaginal<br /><br>microbiota over time, the sequencing results will be depicted in heatmaps.<br /><br>Furthermore, independent determinants for fluctuations in the composition of<br /><br>the vaginal microbiota will be determined by logistic regression analysis,<br /><br>linear discriminant analysis effect size, and principal component analysis.<br /><br>We will also track specific bacterial species that are associated with the<br /><br>normal vaginal microbiota and with BV, such as lactobacillus species,<br /><br>Gardenerella vaginalis, and Atopobium vaginae.<br /><br>We will use Nugent scoring and Amsel criteria to determine the BV status over<br /><br>time.</p><br>

Secondary Outcome Measures