Clinical Research Directory

Effect of Hifas Intima Oral on Vaginal Microbiota in Healthy Women

Sponsor: Hifas da Terra S.L.

Summary

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

Official title: Open-label Clinical Trial to Evaluate the Effect of the Hifas Intima Food Supplement on the Vaginal Microbiota of Healthy Women

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