Effect of Hifas Intima Oral on Vaginal Microbiota in Healthy Women

NCT07715058 | Completed

• 1 other identifier: HIFAS-2025-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Vaginal microbiome; Oral probiotic supplementation; Dietary supplement; Vaginal pH; Vaginal Health Index; Lactobacillus crispatus; Lactobacillus gasseri; Lactobacillus jensenii; Women's health

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline and week 12

Secondary Outcomes (5)

• Change from baseline in Vaginal Health Index score

  Baseline and week 12

• Number of participants with adverse events during Hifas Intima supplementation

  From the first dose through week 12

• Number of participants who rated Hifas Intima as tolerable

  Week 12

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

  From the first dose through week 12, assessed at week 12

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

  Week 12

Study Arms (1)

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.

Dietary Supplement: Hifas INTIMA Oral

Interventions

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.

Hifas Intima Oral

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hifas da Terra S.L.: lead

Study Sites (1)

Instituto Palacios, Salud y Medicina de la Mujer

Madrid, Madrid, 28009, Spain

Location

Study Officials

• Santiago Palacios Gil-Antuñano

  Instituto Palacios, Salud y Medicina de la Mujer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All participants received one capsule of Hifas Intima orally once daily for 12 weeks.

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 20, 2026
• Study Start: June 11, 2025
• Primary Completion: March 17, 2026
• Study Completion: March 17, 2026
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)