Microbiota, Vaginal Microbiome, Vaginal Microbiota
Conditions
Keywords
Vaginal microbiome, Oral probiotic supplementation, Dietary supplement, Vaginal pH, Vaginal Health Index, Lactobacillus crispatus, Lactobacillus gasseri, Lactobacillus jensenii, Women's health
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
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.
Interventions
DIETARY_SUPPLEMENTHifas 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
Hifas da Terra S.L.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
All participants received one capsule of Hifas Intima orally once daily for 12 weeks.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the relative abundance of Lactobacillus crispatus in the vaginal microbiota | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Vaginal Health Index score | 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. |
| Number of participants with adverse events during Hifas Intima supplementation | 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. |
| Number of participants who rated Hifas Intima as tolerable | 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. |
| Number of participants who followed the prescribed once-daily Hifas Intima supplementation schedule | 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. |
| Participant satisfaction score with Hifas Intima on a 7-Point Likert Scale | 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. |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORSantiago Palacios Gil-Antuñano
Instituto Palacios, Salud y Medicina de la Mujer
Outcome results
None listed