Interventional Study to Evaluate the Effect of a Food Supplement Comprising L. Plantarum After Oral Intake in Vaginal Microbiota
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Colonization
研究概览
简要总结
Vaginal microbiota is abundantly colonized by Lactobacillus genera. When vaginal microbiota gets altered, opportunistic microorganisms may proliferate and become abundant species giving rise to dysbiosis.
Probiotics are living organisms that provide the host certain benefits. Despite probiotics have been historically linked to intestinal microbiota, several research groups have published positive results for some Lactobacillus strains in vaginal microbiota. The Lactobacillus strain investigated in the presented project showed the ability to prevent recurrent vaginal Candidiasis in women with high vaginal candidiasis prevalence.
Nowadays the Lactobacillus strain here investigated is commercialized as vaginal caps, however oral intake is widely preferred among consumers. Because of that, this study aims to determine whether this Lactobacillus strain is able to colonize vaginal microbiota when administered orally.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Asymptomatic subjects with vaginal microbiota classified as LBG (Lactobacillary grade) I, IIa or IIb.
- •Using the same contraceptive within 4 weeks prior to study start.
排除标准
- •Current vaginal infection.
- •Vaginal infection 1 month prior to study start.
- •Cervico-vaginal pathology.
- •Papilloma human virus.
- •Pregnant or breastfeeding mothers.
- •Using IUD.
- •Immunomodulators or systemic corticoids intake.
- •Vaginal or systemic antibiotics intake 1 month prior to study start.
- •Vaginal probiotic intake 1 month prior to study start.
- •Less than three months after giving birth or abortion.
- •Undergone vaginal or intestinal surgery three months prior to study start.
- •Severe stress or depression.
- •Systemic acute or severe disease.
- •History of alcohol or drug abuse.
- •Chronic intestinal pathology.
- •Not understanding protocol procedures.
- •Use of lubricant 24 hours or spermicide 7 days prior to study start.
- •Swallowing difficulties.
- •Impossibility to understand study procedures.
- •Enrolled in another clinical study.
- •Atrophic vaginitis not under treatment
结局指标
主要结局
Colonization
时间窗: change day 42 from baseline
Determine the relative presence of Lactobacillus plantarum in vaginal microbiota by metagenomic analysis
次要结局
- Vaginal pH(Change day 42 from baseline)
- Product satisfaction(day 14-23)
- Safety and tolerability(through study completion, an average of 42 days)
- Lactobacillary grade (LBG) score(change day 42 from baseline)
- Other bacteria in vagina(change day 42 from baseline)
- Gastrointestinal symptoms(Change day 14-23 from baseline)