NCT05176535已完成不适用
Study to Determine Vaginal Colonization and Effect of an Oral Probiotic That Contains L.Rhamnosus, L. Plantarum and L. Crispatus in Women (PROSALVAG)
Fertypharm2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2021年10月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Rectal and vaginal colonization
研究概览
简要总结
The aim of this study is to determine the efficacy of an oral nutraceutical with probiotics in restore vaginal health.
详细描述
After being informed about the study, all patients meeting the inclusion/exclusion criteria and giving written informed consent will receive a nutraceutical containing L. rhamnosus, L. plantarum and L. crispatus once daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged: 35-43 years old
- •Vaginal pH > 4,5 and low Lactobacillus count or Nugent score of 4-6
- •With interest in getting pregnant and ideally in IVF waiting list
- •History of recurrent genitourinary infections
排除标准
- •Any pathology that interferes with the study
- •Current intake of food supplements or probiotics
- •Current intake of contraceptives
- •Use of oral or vaginal probiotics in the last 6 months
- •Hypersensitivity to any of the components of the studied product
- •Current vaginal infection
- •Pregnant women
- •Breastfeeding
- •Use of intrauterine device
- •Use of spermicide
- •Use of cervical caps as hormonal therapy
结局指标
主要结局
Rectal and vaginal colonization
时间窗: 10 weeks
Rectal and vaginal colonization will be evaluated by measuring massive sequencing of 16SrRNA gen
次要结局
- Antioxidant effect(10 weeks)
- Autoinmune capacity(10 weeks)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Probiotic Modulates Vaginal MicrofloraMicrobial ColonizationNCT05302687Min-Tze LIONG112
已完成
不适用
Orall Administered Probiotics to Improve the Quality of the Vaginal Flora of Women With Breast Cancer and Chemotherapy.Breast CancerNCT01723592Medical University of Vienna27
已完成
不适用
Vaginal Probiotics and Pessaries and Their Impact on the Vaginal MicroenvironmentPelvic Organ ProlapseInflammatory ResponseDysbiosisNCT04118049Hartford Hospital141
已完成
不适用
Analysis of Ameliorative Effects of Oral Probiotics on Bacterial VaginosisBacterial VaginosisNCT03116789GenMont Biotech Incorporation43
Unknown
不适用
The Efficacy and Mechanisms of Oral Probiotics in Preventing Necrotizing EnterocolitisDeathNecrotizing EnterocolitisNCT02552706Shenzhen Bao'an Maternal and Child Health Hospital270