Menstrual Pads
OtherParticipants adopt menstrual pads to manage their menstruation during 2 menstrual cycles. For each menstrual cycle, participants will provide vaginal microbiome samples via self-sampled swabs at 3 points.
NCT Number: NCT06646185
A three-period crossover trial will study the effects of short-term use of 3 menstrual products (menstrual pad, tampon, menstrual cup) on the bacterial composition of the vaginal microbiome in three countries (Peru, Cameroon, and Switzerland). Each crossover period consists of two menstrual cycles, thus resulting in a 6-month trial. Participants will be randomly assigned to one of 6 exposure sequences (different order of products per sequence); in each sequence, participants will adopt each menstrual product for 2 menstrual cycles. Participants will provide vaginal microbiome samples via self-sample swabs at 3 points during each menstrual cycle. Given the crossover design of the study, there is not a dedicated control group.
Interested in participating?
Request Info18 year–35 year
Female
Interventional
Not applicable
Centre de Recherche sur les Maladies Emergentes et Re-Emergentes, Yaoundé, Cameroon
In three countries, the investigators will follow a randomized crossover design to study the effects of menstrual products on the vaginal microbiome composition and diversity. Eligible participants who are willing to adopt pads, tampons and menstrual cups to manage their menstruation, and for which baseline composition of their vaginal microbiomes is determined through DNA sequencing of the 16s rRNA gene will enter a three-period crossover trial. Each period of the trial will consist of two menstrual cycles, thus resulting in a 6-month trial. Participants will be randomly assigned to one of six different exposure sequences of menstrual products, as follows:
i) Tampon, Cup, Pad ii) Tampon, Pad, Cup iii) Cup, Tampon, Pad iv) Cup, Pad, Tampon v) Pad, Tampon, Cup vi) Pad, Cup, Tampon
In group "i)", participants will adopt tampons during the first two menstrual cycles (first period of the trial), followed by the adoption of cups during the next two menstrual cycles (second period), and lastly menstrual pads for the next two menstrual cycles (third crossover period). In groups ii) to vi) following the same design but in different sequences. Self-sampling kits will be provided during six consecutive menstrual cycles, a few days before the start of menses. Each kit will contain swabs for three self-sampling points during the menstrual cycle and the corresponding menstrual products.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants adopt menstrual pads to manage their menstruation during 2 menstrual cycles. For each menstrual cycle, participants will provide vaginal microbiome samples via self-sampled swabs at 3 points.
Participants adopt menstrual cups to manage their menstruation during 2 menstrual cycles. For each menstrual cycle, participants will provide vaginal microbiome samples via self-sampled swabs at 3 points.
Participants adopt tampons to manage their menstruation during 2 menstrual cycles. For each menstrual cycle, participants will provide vaginal microbiome samples via self-sampled swabs at 3 points.
Time frame: Monthly, after menstruation ends, through study completion, an average of 6 months.
The abundances of each bacterial taxa are estimated from the DNA amplification and sequencing of amplicons from the 16S rRNA gene.
Time frame: Monthly, after menstruation ends, through study completion, an average of 6 months.
The abundances of each bacterial taxa are estimated from the DNA amplification and sequencing of amplicons from the 16S rRNA gene.
Time frame: Monthly, after menstruation ends, through study completion, an average of 6 months.
The abundances of each bacterial taxa are estimated from the DNA amplification and sequencing of amplicons from the 16S rRNA gene.
Time frame: Monthly, after menstruation ends, through study completion, an average of 6 months.
The dominant taxon in a vaginal swab is defined as the most abundant taxon found with a relative abundance of at least 30% of the total bacterial DNA sequences found in the sample.
Time frame: Monthly, after menstruation ends, through study completion, an average of 6 months.
The community state type in a vaginal swab is defined using the VALENCIA algorithm as described in this article: France, M.T., Ma, B., Gajer, P. et al. VALENCIA: a nearest centroid classification method for vaginal microbial communities based on composition. Microbiome 8, 166 (2020). https://doi.org/10.1186/s40168-020-00934-6
Time frame: Monthly, after menstruation ends, through study completion, an average of 6 months.
Indirectly estimated with qPCR of the 16S rRNA gene
Time frame: Monthly, from enrollment until study completion, an average of 6 months.
Self-reported through follow up surveys along the six-month trial
Time frame: Monthly, after menstruation ends, through study completion, an average of 6 months.
Measured with a vaginal swab and a fixed indicator (3.6 - 6.1), just after menstruation ends.
Time frame: Monthly, after menstruation ends, through study completion, an average of 6 months.
Alpha diversity indices (e.g., Shannon, Simpson) are estimated for each vaginal swab sample to quantify microbial richness and evenness.
Time frame: Monthly, after menstruation ends, through study completion, an average of 6 months.
The abundances of each bacterial module are estimated from the DNA amplification and sequencing of amplicons from the 16S rRNA gene.
Time frame: Monthly, after menstruation ends, through study completion, an average of 6 months.
The abundances of each bacterial module are estimated from the DNA amplification and sequencing of amplicons from the 16S rRNA gene.
Time frame: Monthly, after menstruation ends, through study completion, an average of 6 months.
The molBV score in a vaginal swab is defined and derived as described in this article: Usyk, M., Schlecht, N.F., Pickering, S. et al. molBV reveals immune landscape of bacterial vaginosis and predicts human papillomavirus infection natural history. Nat Commun 13, 233 (2022). https://doi.org/10.1038/s41467-021-27628-3.
Contact information is provided by the study sponsor or research team.
Monica Ticlla, PhD
CONTACT
Sonja Merten, MD MPH PhD
CONTACT
Swiss Tropical & Public Health Institute
Other
IMVAHA: Improving Menstrual and VAginal Health for All
Acronym: IMVAHA
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