Effect of Hifas Intima Oral on Vaginal Microbiota in Healthy Women

Overview

The goal of this clinical trial was to learn whether the vaginal microbiota changed after healthy women aged 18 to 45 years took Hifas Intima, an oral food supplement, for 3 months. The study also evaluated changes in vaginal pH and vaginal health and collected information about adverse events, tolerability, adherence, and participant satisfaction. The main questions it aimed to answer were: Did the composition of the vaginal microbiota change after participants took Hifas Intima for 3 months? Did vaginal pH or vaginal health change during the study? What medical problems or tolerability issues did participants have while taking Hifas Intima? How closely did participants follow the supplementation schedule, and how satisfied were they with the supplement? All participants received Hifas Intima. The study did not include a placebo or another comparison group. Participants were asked to: Take one capsule of Hifas Intima by mouth once daily for 12 weeks Attend one study visit before starting supplementation and another visit after 3 months Provide vaginal samples at both visits to assess the vaginal microbiota Undergo gynecological assessments, including measurement of vaginal pH and vaginal health Have a urine pregnancy test at both visits Report medical problems and provide information about tolerability, adherence, and satisfaction with the supplement

This was a prospective, single-center, single-group, open-label, pre-post interventional study conducted at Instituto Palacios, Salud de la Mujer, in Madrid, Spain. The study enrolled 30 women aged 18 to 45 years who were asymptomatic or had nonspecific vaginal symptoms and who did not have a diagnosed specific vaginal infection. Women receiving treatment for a vaginal infection or using probiotics at enrollment were excluded. After providing written informed consent and meeting the eligibility criteria, all participants received one capsule of the oral food supplement Hifas Intima once daily for 12 weeks. The study did not include randomization, placebo, an active comparator, or masking. Participants attended a baseline visit and a follow-up visit after 12 weeks. Vaginal samples were collected at both visits. Vaginal microbiota composition was assessed using next-generation sequencing to determine the relative abundance of vaginal microorganisms, including clinically relevant Lactobacillus species such as Lactobacillus crispatus, Lactobacillus gasseri, and Lactobacillus jensenii. Vaginal pH and vaginal health, assessed using the Vaginal Health Index, were also measured at both visits. The primary objective was to evaluate changes in vaginal microbiota composition from baseline to 12 weeks. Secondary objectives were to evaluate changes in vaginal pH and vaginal health and to assess adverse events, tolerability, adherence to supplementation, and participant satisfaction. Because all participants received the same intervention and there was no comparison group, outcomes were evaluated by comparing each participant's follow-up measurements with her baseline measurements.