Improving Menstrual and VAginal Health for All
- Conditions
- Effects of Menstrual Products on the Vaginal Microbiome
- Registration Number
- NCT06646185
- Lead Sponsor
- Swiss Tropical & Public Health Institute
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 100
- able to provide informed consent;
- no major pre-existing health conditions;
- no current use of antibiotics at enrollment
- 18-45 years old;
- residing in Yaounde/Gounougou (Cameroon), Maynas/Loreto/Lima provinces (Peru), or Basel/Zurich cantons (Switzerland);
- has experienced a menstrual period lasting at least 3 days for at least the last 4 months
- has consistent monthly menstrual cycles lasting 21-35 days for at least the last 4 months
- negative to the detection of the toxic shock syndrome toxin-1 gen (tst) using PCR.
Participants will be excluded if they do not meet the above criteria and/ or meet any of the following:
- had a menstrual abnormality with any of the last menstrual cycles in the last 4 months (such as oligomenorrhea or amenorrhea, or bleed more than 7 days a month)
- Pregnant or actively trying to become pregnant
- Breastfeeding
- vaginal delivery in the last 6 months
- vaginal surgery, perineal surgery, uterine surgery, miscarriage or abortion in the last 6 months
- has history of Toxic Shock Syndrome (TSS)
- positive to detection of the toxic shock syndrome toxin-1 gen (tst) using PCR
- IUD in situ.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Log-ratio of Dialister to Lactobacillus crispatus relative abundances in vaginal swabs 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.
- Secondary Outcome Measures
Name Time Method Log-ratio of Bifidobacterium vaginalis to Lactobacillus relative abundances in vaginal swabs 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.
Log-ratio of Prevotella to Lactobacillus relative abundances in vaginal swabs 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.
Dominant taxon in vaginal swabs 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.
Community state type in vaginal swabs Monthly, after menstruation ends, through study completion, an average of 6 months. The community state type in a vaginal swab is defined 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
Total bacterial load in vaginal swabs Monthly, after menstruation ends, through study completion, an average of 6 months. Indirectly estimated with qPCR of the 16S rRNA gene
Self-reported vaginal complaints Monthly, from enrollment until study completion, an average of 6 months. Self-reported through follow up surveys along the six-month trial
Vaginal pH Monthly, after menstruation ends, through study completion, an average of 6 months. Measured with a vaginal swab just after menstruation ends.
Alpha diversity Monthly, after menstruation ends, through study completion, an average of 6 months. Microbial diversity indices are estimated for each sample.
Trial Locations
- Locations (3)
Centre de Recherche sur les Maladies Emergentes et Re-Emergentes
🇨🇲Yaoundé, Cameroon
Universidad Nacional de la Amazonia Peruana
🇵🇪Iquitos, Peru
Swiss Tropical and Public Health Institute
🇨🇭Allschwil, Switzerland