Dietary Supplementation of Lactogyn in Women With Bacterial Vaginosis: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- Percent change in recurrence of BV during Lactogyn supplementation
研究概览
简要总结
The objective of the study is to determine clinical efficacy of Lactogyn (Lactobacillus Crispatus, L. brevis, L.acidophilus) in prevention of recurrent BV
详细描述
According to classification, this is a phase 2 randomized parallel group prospective controlled dietary study to evaluate efficacy of a dietary supplement, a combination of L. crispatus LMG S-29995, L. brevis, and L. acidophilus in women aged from 18 through 45 years suffering from rBV. The 2 phase of the study has been ascribed as there is no evidence that oral capsules with L. crispatus LMG S-29995, L. brevis, and L. acidophilus have a potential efficacy in rBV.
Qualifying women received a combination of the three probiotic strains with a half daily recommended dose of vitamin C or just vitamin C without probiotics, a control supplementation, via oral route of administration for up to 120 days. During the intake of active or control formulations, participants kept a structured 120-DSD, where they recorded test capsules intake, screen for symptoms of bacterial vaginosis, and food intolerance events.
Based on repeat physical examination with application of Amsel and Nugent criteria the main conclusions over the efficacy of probiotic strains were made.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Informed consent form signed;
- •Age: 18-45 years;
- •Able to swallow capsules;
- •Recent symptomatic BV successfully treated with metronidazole tablets in a dose of 500 mg 2 times daily for 7 days;
- •Less than 48 hours after treatment of acute BV defined as three out of four Amsel criteria;
- •Willing to communicate intimate history for the study purposes;
- •Consent not to use spermicides for 4 months after starting TDC;
- •Stated availability throughout the study period and a mobile phone.
排除标准
- •Post-menopausal;
- •Pregnancy or high risk of;
- •Breast feeding;
- •Currently active STD as determined by history, physical examination, and laboratory tests;
- •Diabetes mellitus;
- •Inflammatory bowel disease;
- •Alcohol or drug addiction as guessed by investigator;
- •Absence of refrigerator;
- •Known moderate to severe disease of any systems;
- •Difficulty to comprehend study requirements as judged by physician;
- •Any erosions, herpes like lesions, cervicitis during vaginal examination;
- •Treatment of BV with other than metronidazole antibiotic;
- •Use of any investigational drug within the previous 30 days;
- •Use of drugs that suppress the immune system.
研究组 & 干预措施
Placebo
1 capsule of Placebo Comparator 2 times daily for the first 7 days then 1 time daily for 4 months
干预措施: Placebo (Dietary Supplement)
Lactogyn
1 capsule of Lactogyn 2 times daily for the first 7 days then 1 time daily for 4 months
干预措施: Lactogyn (Dietary Supplement)
结局指标
主要结局
Percent change in recurrence of BV during Lactogyn supplementation
时间窗: 4 months
Percent change in recurrence of BV during the 4 months of dietary supplementation
次要结局
未报告次要终点