Open-label Clinical Trial to Evaluate the Effect of the Hifas Intima Food Supplement on the Vaginal Microbiota of Healthy Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change from baseline in the relative abundance of Lactobacillus crispatus in the vaginal microbiota
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Hifas Intima Oral
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.
干预措施: Hifas INTIMA Oral (Dietary Supplement)
结局指标
主要结局
Change from baseline in the relative abundance of Lactobacillus crispatus in the vaginal microbiota
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Change from baseline in Vaginal Health Index score(Baseline and week 12)
- Participants with adverse events(From the first dose through week 12)
- Participant-Reported tolerability(Week 12)
- Adherence(From the first dose through week 12, assessed at week 12)
- Participant satisfaction(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)