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| Name | Class |
|---|---|
| Universidad Nacional de la Amazonia Peruana | UNKNOWN |
| Universidad Peruana Cayetano Heredia | OTHER |
| Centre de Recherche sur les Maladies Emergentes et Re-Emergentes | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TamponCupPad | Other | Participants will adopt tampons during the first two menstrual cycles (first period of the trial), followed by adoption of cups during the next two menstrual cycles (second period), and lastly menstrual pads for the next two menstrual cycles (third crossover period). |
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| TamponPadCup | Other | Participants will adopt tampons during the first two menstrual cycles (first period of the trial), followed by adoption of pads during the next two menstrual cycles (second period), and lastly menstrual cups for the next two menstrual cycles (third crossover period). |
|
| CupTamponPad | Other | Participants will adopt menstrual cups during the first two menstrual cycles (first period of the trial), followed by adoption of tampons during the next two menstrual cycles (second period), and lastly menstrual pads for the next two menstrual cycles (third crossover period). |
|
| CupPadTampon | Other | Participants will adopt menstrual cups during the first two menstrual cycles (first period of the trial), followed by adoption of menstrual pads during the next two menstrual cycles (second period), and lastly tampons for the next two menstrual cycles (third crossover period). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Menstrual Pads | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Monthly, after menstruation ends, through study completion, an average of 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Monthly, after menstruation ends, through study completion, an average of 6 months. |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sonja Merten, MD MPH PhD | Contact | 0041-61-284-8387 | sonja.merten@swisstph.ch | |
| Monica Ticlla, PhD | Contact | 0041-61-284-8387 | monicaroxana.ticllaccenhua@swisstph.ch |
| Name | Affiliation | Role |
|---|---|---|
| Sonja Merten, PhD | Swiss Tropical & Public Health Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Recherche sur les Maladies Emergentes et Re-Emergentes | Recruiting | Yaoundé | Yaoundé | 3 | Cameroon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42020126 | Derived | Ticlla MR, Dumbaugh M, Condori-Catachura S, Kenfack J, Hattendorf J, Van Der Donck L, Arista KM, Arora N, Gebert S, Ackermann L, Ahannach S, Riveros M, Blas MM, Kenmoe S, Barriere FY, Shea AA, Pinedo-Cancino V, Rivas-Ruiz R, Di Cecco V, Esemu L, Ochoa TJ, Lebeer S, Martin Hilber A, Merten S. Improving menstrual and vaginal health for all (IMVAHA): protocol for a randomised cross-over trial assessing the impact of menstrual products on the vaginal microbiome of women aged 18-35 years in Cameroon, Peru and Switzerland. BMJ Open. 2026 Apr 22;16(4):e108568. doi: 10.1136/bmjopen-2025-108568. |
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| ID | Term |
|---|---|
| D052576 | Menstrual Hygiene Products |
| ID | Term |
|---|---|
| D053566 | Feminine Hygiene Products |
| D004864 | Equipment and Supplies |
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| Universiteit Antwerpen |
| OTHER |
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. No wash-out period is included because participants can not stop the use of menstrual products to manage their menstruation.
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| PadTamponCup | Other | Participants will adopt menstrual pads during the first two menstrual cycles (first period of the trial), followed by adoption of tampons during the next two menstrual cycles (second period), and lastly menstrual cups for the next two menstrual cycles (third crossover period). |
|
| PadCupTampon | Other | Participants will adopt menstrual pads during the first two menstrual cycles (first period of the trial), followed by adoption of menstrual cups during the next two menstrual cycles (second period), and lastly tampons for the next two menstrual cycles (third crossover period). |
|
| Menstrual Cups | Other | 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. |
|
| Tampons | Other | 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. |
|
| 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. |
| Monthly, after menstruation ends, through study completion, an average of 6 months. |
| 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. | Monthly, after menstruation ends, through study completion, an average of 6 months. |
| 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 | Monthly, after menstruation ends, through study completion, an average of 6 months. |
| Total bacterial load in vaginal swabs (continuous variable) | Indirectly estimated with qPCR of the 16S rRNA gene | Monthly, after menstruation ends, through study completion, an average of 6 months. |
| Self-reported vaginal complaints (discrete variable) | Self-reported through follow up surveys along the six-month trial | Monthly, from enrollment until study completion, an average of 6 months. |
| Vaginal pH (ordinal variable) | Measured with a vaginal swab and a fixed indicator (3.6 - 6.1), just after menstruation ends. | Monthly, after menstruation ends, through study completion, an average of 6 months. |
| Alpha diversity (continuous variable) | Alpha diversity indices (e.g., Shannon, Simpson) are estimated for each vaginal swab sample to quantify microbial richness and evenness. | Monthly, after menstruation ends, through study completion, an average of 6 months. |
| Log-ratio of Gardnerella module to L. crispatus module relative abundances (continuous variable) | The abundances of each bacterial module are estimated from the DNA amplification and sequencing of amplicons from the 16S rRNA gene. | Monthly, after menstruation ends, through study completion, an average of 6 months. |
| Log-ratio of Prevotella module to L. crispatus module relative abundances (continuous variable) | The abundances of each bacterial module are estimated from the DNA amplification and sequencing of amplicons from the 16S rRNA gene. | Monthly, after menstruation ends, through study completion, an average of 6 months. |
| molBV score (discrete variable) | 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. | Monthly, after menstruation ends, through study completion, an average of 6 months. |
| Universidad Nacional de la Amazonia Peruana | Recruiting | Iquitos | Iquitos | 16007 | Peru |
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| Swiss Tropical and Public Health Institute | Recruiting | Allschwil | Allschwil | 4123 | Switzerland |
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