Clinical trial NCT06646185: Improving Menstrual and VAginal Health for All
Official title: IMVAHA: Improving Menstrual and VAginal Health for All
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Effects of Menstrual Products on the Vaginal Microbiome
Keywords: vaginal microbiome
menstruation
crossover study
menstrual products
Lead sponsor: Swiss Tropical & Public Health Institute
Sponsor class: OTHER
Collaborators: name: Universidad Nacional de la Amazonia Peruana
name: Universidad Peruana Cayetano Heredia
name: Centre de Recherche sur les Maladies Emergentes et Re-Emergentes
name: Universiteit Antwerpen
First posted: 2024-10-17
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

* able to provide informed consent;
* no major pre-existing health conditions;
* no current use of antibiotics at enrollment
* 18-35 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.

Exclusion Criteria: 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.

Primary outcomes:
measure: Log-ratio of Dialister to Lactobacillus crispatus relative abundances in vaginal swabs
timeFrame: Monthly, after menstruation ends, through study completion, an average of 6 months.
Secondary outcomes:
measure: Log-ratio of Bifidobacterium vaginalis to Lactobacillus relative abundances in vaginal swabs
timeFrame: Monthly, after menstruation ends, through study completion, an average of 6 months.
measure: Log-ratio of Prevotella to Lactobacillus relative abundances in vaginal swabs
timeFrame: Monthly, after menstruation ends, through study completion, an average of 6 months.
measure: Dominant taxon in vaginal swabs
timeFrame: Monthly, after menstruation ends, through study completion, an average of 6 months.
measure: Community state type in vaginal swabs
timeFrame: Monthly, after menstruation ends, through study completion, an average of 6 months.
measure: Total bacterial load in vaginal swabs
timeFrame: Monthly, after menstruation ends, through study completion, an average of 6 months.
measure: Self-reported vaginal complaints
timeFrame: Monthly, from enrollment until study completion, an average of 6 months.
measure: Vaginal pH
timeFrame: Monthly, after menstruation ends, through study completion, an average of 6 months.
measure: Alpha diversity
timeFrame: Monthly, after menstruation ends, through study completion, an average of 6 months.
Other outcomes:
Locations:
city: Yaoundé
country: Cameroon
facility: Centre de Recherche sur les Maladies Emergentes et Re-Emergentes
city: Iquitos
country: Peru
facility: Universidad Nacional de la Amazonia Peruana
city: Allschwil
country: Switzerland
facility: Swiss Tropical and Public Health Institute
Study officials:
affiliation: Swiss Tropical & Public Health Institute
name: Sonja Merten, PhD
role: PRINCIPAL_INVESTIGATOR
References: