Improving Menstrual and VAginal Health for All
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorSwiss Tropical & Public Health Institute
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
able to provide informed consent;
aged 18-35;
residing in the recruitment region and expecting to reside in the same region for at least six months following recruitment (Yaoundé/ Gounougou, Cameroon; Loreto/Lima/Maynas provinces, Peru; or Basel-Landschaft and Basel-Stadt cantons, Switzerland);
are native speakers or are able to read and understand one of the following languages in each respective country (German, French, Italian, English or Spanish in Switzerland; French or English in Cameroon; Spanish in Peru);
Disqualifiers
experienced a menstrual abnormality with any of the menstrual cycles in the last 4 months (such as oligomenorrhea or amenorrhea, or bleed more than 7 days a month);
are pregnant or actively trying to become pregnant;
are breastfeeding;
used antibiotics and/or vaginal antifungals in the last 30 days prior to recruitment;
Trial design
Design model
Crossover
Treatments tested in this trial
Menstrual Pads
Other interventionParticipants 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.
Menstrual Cups
Other interventionParticipants 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.
Tampons
Other interventionParticipants 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.
Treatment groups
100 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: TamponCupPadOther 3 interventions
Group B: TamponPadCupOther 3 interventions
Group C: CupTamponPadOther 3 interventions
Group D: CupPadTamponOther 3 interventions
Group E: PadTamponCupOther 3 interventions
Group F: PadCupTamponOther 3 interventions
Trial outcomes
Primary outcomes
1
Log-ratio of Dialister to Lactobacillus crispatus relative abundances in vaginal swabs (continuous variable)
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.Secondary outcomes
1
Log-ratio of Bifidobacterium vaginalis to Lactobacillus relative abundances in vaginal swabs (continuous variable)
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.2
Log-ratio of Prevotella to Lactobacillus relative abundances in vaginal swabs (continuous variable)
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.3
Dominant taxon in vaginal swabs (categorical variable)
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.4
Community state type in vaginal swabs (categorical variable)
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Swiss Tropical & Public Health Institute
Lead sponsor
Universidad Nacional de la Amazonia Peruana
Collaborator
Universidad Peruana Cayetano Heredia
Collaborator
Centre de Recherche sur les Maladies Emergentes et Re-Emergentes
Collaborator
Universiteit Antwerpen
Collaborator
Source ClinicalTrials.gov