Skip to main content
OpenTrials
Completed

NCT Number: NCT07715058

Effect of Hifas Intima Oral on Vaginal Microbiota in Healthy Women

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Vaginal Microbiota Microbiota Vaginal Microbiome

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Palacios, Salud y Medicina de la Mujer

Madrid, 28009, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female participants aged 18 to 45 years
  • Able and willing to provide written informed consent, participate in the study, and follow the study supplementation schedule and procedures
  • No symptoms, or only nonspecific symptoms not attributed to a diagnosed vaginal infection

Exclusion criteria

  • Unexplained vaginal bleeding
  • Suspected or diagnosed cancer
  • Known intolerance, allergy, or hypersensitivity to any component of Hifas Intima Oral
  • An immunosuppressive disorder or human immunodeficiency virus infection
  • Current use of probiotics by any route of administration
  • A diagnosed specific vaginal infection or current treatment for a vaginal infection
  • A poorly controlled chronic noncommunicable disease, such as diabetes mellitus, Hashimoto thyroiditis, or heart disease
  • Pregnancy or planning to become pregnant
  • Premature menopause

Treatment and study plan

Hifas INTIMA Oral

Dietary Supplement

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.

Primary outcomes

  1. Change from baseline in the relative abundance of Lactobacillus crispatus in the vaginal microbiota

    Time frame: Baseline and week 12

    Vaginal samples were collected at baseline and week 12 and analyzed using next-generation sequencing. The relative abundance of Lactobacillus crispatus was expressed as the percentage of the vaginal bacterial community assigned to this species. Change was calculated as the week 12 percentage minus the baseline percentage and was expressed in percentage points. Positive values indicate an increase in relative abundance.

  2. Change from baseline in the relative abundance of Lactobacillus gasseri in the vaginal microbiota

    Time frame: Baseline and week 12

    Vaginal samples were collected at baseline and week 12 and analyzed using next-generation sequencing. The relative abundance of Lactobacillus gasseri was expressed as the percentage of the vaginal bacterial community assigned to this species. Change was calculated as the week 12 percentage minus the baseline percentage and was expressed in percentage points. Positive values indicate an increase in relative abundance.

  3. Change from baseline in the relative abundance of Lactobacillus jensenii in the vaginal microbiota

    Time frame: Baseline and week 12

    Vaginal samples were collected at baseline and week 12 and analyzed using next-generation sequencing. The relative abundance of Lactobacillus jensenii was expressed as the percentage of the vaginal bacterial community assigned to this species. Change was calculated as the week 12 percentage minus the baseline percentage and was expressed in percentage points. Positive values indicate an increase in relative abundance.

Secondary outcomes

  1. Change from baseline in Vaginal Health Index score

    Time frame: Baseline and week 12

    Vaginal health was assessed using the Vaginal Health Index, also referred to in the protocol as the Bachmann Vaginal Health Index. The total score ranges from 5 to 25, with higher scores indicating better vaginal health. Change was calculated as the week 12 total score minus the baseline total score. Positive values indicate improvement.

  2. Number of participants with adverse events during Hifas Intima supplementation

    Time frame: From the first dose through week 12

    The number and percentage of participants who experienced one or more adverse events during the supplementation period were assessed. Adverse events were collected at the week 12 visit and were to be described according to their nature and severity.

  3. Number of participants who rated Hifas Intima as tolerable

    Time frame: Week 12

    Tolerability was assessed at week 12 using a study-specific yes-or-no assessment. The number and percentage of participants who reported that the supplement was tolerable were summarized. Discontinuations attributed to poor tolerability were also recorded.

  4. Number of participants who followed the prescribed once-daily Hifas Intima supplementation schedule

    Time frame: From the first dose through week 12, assessed at week 12

    Adherence during the 12-week supplementation period was assessed using the participant medication diary and returned product packaging. The diary and returned packaging were reviewed at the week 12 visit to determine whether participants followed the prescribed once-daily supplementation schedule.

  5. Participant satisfaction score with Hifas Intima on a 7-Point Likert Scale

    Time frame: Week 12

    At week 12, participants rated their overall satisfaction with Hifas Intima Oral using a 7-point Likert-type scale. Scores ranged from 1 to 7, with higher scores indicating greater satisfaction with the supplement.

Sponsors and collaborators

Lead sponsor

Hifas da Terra S.L.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 20, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.