Vaginal MicrobiotaNCT07715058
Effect of Hifas Intima Oral on Vaginal Microbiota in Healthy Women
A study testing Hifas INTIMA Oral in people with Vaginal Microbiota and Microbiota, run by Hifas da Terra S.L. at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Microbiota, Microbiota, Vaginal Microbiome
- What is being tested?
- Hifas INTIMA Oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 11 Jun 2025to 17 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- A poorly controlled chronic noncommunicable disease, such as diabetes mellitus, Hashimoto thyroiditis, or heart disease
- Pregnancy or planning to become pregnant
- Premature menopause
Trial locations and contacts
1 site in 1 country.
Spain1 site
Instituto Palacios, Salud y Medicina de la Mujer
Madrid, Madrid, 28009
About this study
Official title: Open-label Clinical Trial to Evaluate the Effect of the Hifas Intima Food Supplement on the Vaginal Microbiota of 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:
Read more
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
Read the detailed description
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.
- Conditions
- Vaginal Microbiota, Microbiota, Vaginal Microbiome
- Being tested
- Hifas INTIMA Oral
- Keywords
- Vaginal microbiome, Oral probiotic supplementation, Dietary supplement, Vaginal pH, Vaginal Health Index, Lactobacillus crispatus, Lactobacillus gasseri, Lactobacillus jensenii, Women's health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hifas INTIMA OralDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Hifas Intima Oral | Experimental | Participants received one capsule of Hifas Intima orally once daily for 12 weeks. All participants received the same intervention. No placebo or active comparator was used. Receives: Dietary Supplement: Hifas INTIMA Oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the relative abundance of Lactobacillus crispatus in the vaginal microbiota
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.
Measured: Baseline and week 12
Change from baseline in the relative abundance of Lactobacillus gasseri in the vaginal microbiota
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.
Measured: Baseline and week 12
Change from baseline in the relative abundance of Lactobacillus jensenii in the vaginal microbiota
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.
Measured: Baseline and week 12
Secondary outcomes (5)
Change from baseline in Vaginal Health Index score
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.
Measured: Baseline and week 12
Number of participants with adverse events during Hifas Intima supplementation
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.
Measured: From the first dose through week 12
Number of participants who rated Hifas Intima as tolerable
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.
Measured: Week 12
Number of participants who followed the prescribed once-daily Hifas Intima supplementation schedule
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.
Measured: From the first dose through week 12, assessed at week 12
Participant satisfaction score with Hifas Intima on a 7-Point Likert Scale
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.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start11 Jun 2025
- Primary completion17 Mar 2026
- Study completion17 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal MicrobiotaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants received one capsule of Hifas Intima orally once daily for 12 weeks.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hifas da Terra S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Santiago Palacios Gil-Antuñano, Principal investigator, Instituto Palacios, Salud y Medicina de la Mujer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715058
- Sponsor's protocol ID
- HIFAS-2025-001
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be made available. The study protocol did not establish a prospective plan, repository, data dictionary, access criteria, or governance process for sharing participant-level data with external researchers. Study data will be maintained confidentially and handled in accordance with applicable data-protection requirements. Only aggregate, non-identifiable study results may be reported.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Clinical Trial to Evaluate the Effect of the Hifas Intima Food Supplement on the Vaginal Microbiota of Healthy Women
- ClinicalTrials.gov ID
- NCT07715058
- Acronym / sponsor ID
- HIFAS-2025-001
- Conditions
- Vaginal Microbiota, Microbiota, Vaginal Microbiome
- Keywords
- Vaginal microbiome, Oral probiotic supplementation, Dietary supplement, Vaginal pH, Vaginal Health Index, Lactobacillus crispatus, Lactobacillus gasseri, Lactobacillus jensenii
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hifas da Terra S.L.Industry (pharma, biotech, devices)
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- 17 Mar 2026 (actual)
- Study completion
- 17 Mar 2026 (actual)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants received one capsule of Hifas Intima orally once daily for 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Hifas Intima Oral | Experimental | Dietary Supplement: Hifas INTIMA OralParticipants received one capsule of Hifas Intima orally once daily for 12 weeks. All participants received the same intervention. No placebo or active comparator was used. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hifas INTIMA OralParticipants 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. | Dietary supplement | Hifas Intima Oral |
Primary outcome
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.
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.
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.
5 secondary outcomes
Change from baseline in Vaginal Health Index score
Time frame: Baseline and week 12
Number of participants with adverse events during Hifas Intima supplementation
Time frame: From the first dose through week 12
Number of participants who rated Hifas Intima as tolerable
Time frame: Week 12
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
Participant satisfaction score with Hifas Intima on a 7-Point Likert Scale
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No. No individual participant data will be made available. The study protocol did not establish a prospective plan, repository, data dictionary, access criteria, or governance process for sharing participant-level data with external researchers. Study data will be maintained confidentially and handled in accordance with applicable data-protection requirements. Only aggregate, non-identifiable study results may be reported.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Santiago Palacios Gil-Antuñano principal investigator
Instituto Palacios, Salud y Medicina de la Mujer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hifas INTIMA Oral in people with Vaginal Microbiota and Microbiota, run by Hifas da Terra S.L. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the relative abundance of Lactobacillus crispatus in the vaginal microbiota (time frame: Baseline and week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.