Oral Probiotics for the Treatment and Prevention of Vulvovaginal Infections in Pregnancy - Double-blind, Randomized, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 3
- 主要终点
- The rate of women in the second prevention group who developed any vaginal infection (BV/AVF/VVC) during the study period until delivery in the probiotic formula group versus placebo.
研究概览
简要总结
During pregnancy, bacterial vaginosis (BV), abnormal vaginal flora (AVF) and vulvovaginal candidiasis (VVC) are associated with serious complications and discomfort. Yet, treatment options are limited. Lactobacilli administration was suggested to treat and prevent vaginal infections. However, this has not been examined in pregnant women, the information regarding oral treatment is scarce, and the mechanisms in which oral ingestion of probiotics induce vaginal lactobacilli proliferation are not well established. In the present study we will examine if oral probiotics are effective in prevention of vaginal infections by migration of lactobacilli from the digestive system to the vagina in pregnant women.
详细描述
During pregnancy, bacterial vaginosis (BV), abnormal vaginal flora (AVF) and vulvovaginal candidiasis (VVC) are associated with serious complications and discomfort. Yet, treatment options are limited. Lactobacilli administration was suggested to treat and prevent vaginal infections. However, this has not been examined in pregnant women, the information regarding oral treatment is scarce, and the mechanisms in which oral ingestion of probiotics induce vaginal lactobacilli proliferation are not well established.
Working hypothesis: Oral probiotics will be effective in prevention of vaginal infections by migration of lactobacilli from the digestive system to the vagina in pregnant women.
Type of research and methods of data collection: randomized placebo-controlled trial.
Pregnant patients with symptoms consisted with vaginal infection will be examined and vaginal smear will be obtained, according to which the patients will be allocated to the following groups:
Primary prevention - women with normal vaginal flora Secondary prevention - women positive for AVF/BV and/or VVC- those women will be treated with antibiotic and/or antimycotic treatment. Following treatment, another smear will be taken to confirm infection eradication. If infection is still present, additional antibiotic and/or antimycotic treatment will be administered after which additional smear will be taken. Women with normal vaginal flora (after one of two treatments) will be recruited for the secondary prevention group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
The rate of women in the second prevention group who developed any vaginal infection (BV/AVF/VVC) during the study period until delivery in the probiotic formula group versus placebo.
时间窗: Until delivery (around 4 months)
The degree of vaginal lactobacilli colonization in the probiotic formula group versus placebo
时间窗: Around 4 months
Lactobacilli culture will be made from a vaginal specimen. The pattern of bacterial growth will be used for a semi-quantitative interpretation in a scale of 0-no vaginal colonization to 4-substantial colonization.
The rate of women in the primary prevention group, who developed any vaginal infection (BV/AVF/VVC) during the study period until delivery in the probiotic formula group versus placebo.
时间窗: From date of randomization until the date of first documented episode or until delivery (around 4 months)
次要结局
- The rate of women, who suffer from obstetrical complications(From randomization until delivery (around 4 months))
- The rate and type of adverse effects in the probiotic versus placebo groups (e.g gastrointestinal symptoms).(From randomization until two weeks after delivery (around 4 months))
- Number of urinary tract infections during the study period(From randomization until delivery (around 4 months))
- The number of episodes of vaginal infections during pregnancy (either AVF/BV or VVC).(From randomization until delivery (around 4 months))
- The rate of women in the primary prevention group who developed VVC during the study period until delivery in the probiotic formula group versus placebo.(From randomization until delivery (around 4 months))
- The rate of women in the second prevention group who developed AVF/BV during the study period until delivery in the probiotic formula group versus placebo.(From randomization until delivery (around 4 months))
- The rate of women in the primary prevention group who developed AVF/BV during the study period until delivery in the probiotic formula group versus placebo.(From randomization until delivery (around 4 months))
- Duration of time from the beginning of the study until an episode of vaginal infection (either AVF/BV or VVC).(From randomization until delivery (around 4 months))
- The rate of neonatal complications(30 days after delivery)
- The rate of women in the second prevention group who developed VVC during the study period until delivery in the probiotic formula group versus placebo.(From randomization until delivery (around 4 months))