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Effect of Hifas Intima Oral on Vaginal Microbiota in Healthy Women

NCT07715058 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-07-22

No results posted yet for this study

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

Conditions

  • Vaginal Microbiota
  • Microbiota
  • Vaginal Microbiome

Interventions

DIETARY_SUPPLEMENT

Hifas INTIMA Oral

Participants took one capsule of Hifas Intima orally once daily, on an empty stomach before a main meal, for 12 weeks. Each capsule contained Ganoderma lucidum fruiting body powder 200 mg; Salvia lavandulifolia leaf and stem dry extract 53.33 mg, providing 8 mg of ursolic acid; D-mannose; inulin 45 mg; Lactobacillus acidophilus La-14® 8 × 10\^9 colony-forming units; vitamin C 12 mg; Lactobacillus crispatus 1 × 10\^9 colony-forming units; Lactobacillus gasseri 1 × 10\^9 colony-forming units; Lacticaseibacillus rhamnosus HN001™ 2 × 10\^9 colony-forming units; and vitamin A 121 micrograms.

Sponsors & Collaborators

  • Hifas da Terra S.L.

    lead INDUSTRY

Principal Investigators

  • Santiago Palacios Gil-Antuñano · Instituto Palacios, Salud y Medicina de la Mujer

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-11
Primary Completion
2026-03-17
Completion
2026-03-17

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07715058 on ClinicalTrials.gov