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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41739

Enrollment

Registered

2015-05-28

Start date

2015-09-15

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

seksuele gezondheid Bacteriële vaginose disbalance of the vaginal microbiota

Interventions

The over-the-counter available Etos® Intiem vaginale douche and Etos® Intiem vloeistof.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Women of reproductive age between 18-36 years

Exclusion criteria

Exclusion criteria: Pregnancy or pregnancy wish STI diagnosis Age 36 years Irregular menstruation Use of antibiotics in the last 30 days Known gynaecological pathology

Design outcomes

Primary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)