Randomized, Double-blind, Placebo-controlled Study to Evaluate the Vaginal Colonization Capacity, Safety, and Tolerability of Two New Strains of L. Gasseri and L. Crispatus When Administered Orally in Healthy Female Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Colonization of L. crispatus strain in the vagina
研究概览
简要总结
Randomized study to determine whether the vaginally isolated strains of Lactobacillus gasseri and/or Lactobacillus crispatus can colonize the vagina when taken orally for 18 days. Secondary outcomes comprise evaluation of safety, tolerability, impact on vaginal microbiota and vaginal pH
详细描述
Double blind, randomized, placebo-controlled biomedical research study to determine whether supplementation with the vaginally isolated strains of Lactobacillus gasseri and/or Lactobacillus crispatus can colonize the vagina. Healthy women who meet inclusion and exclusion criteria will be randomized 1.5:1.5:1 to one of the following study groups: group one will receive L.gasseri for 18 days (1 capsule/day), group two will recieve the combination of L.gasseri and L.Crispatus for 18 days (1 capsule/day) and the other will receive placebo, starting the day after menstruation is over. Main study outcome will be colonization throughout the study, which will be determined by analysis of specific strains by qPCR. Secondary outcomes comprise comprise evaluation of tolerability, impact on vaginal microbiota, vaginal pH and adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Healthy women
- •Reproductive age 18-45 years
排除标准
- •Vaginal infection or symptoms (AMSEL criteria).
- •Relevant disease (immunodeficiency, cervicovaginal pathology, diabetes, estrogen-dependent tumors, inflammatory bowel disease, atrophic vaginitis, pancreatitis)
- •Suffer from chronic diarrhea or constipation or short bowel syndrome,
- •Having taken systemic or vaginal antibiotics or antifungals during the month prior to study entry.
- •Pregnant women or willing to be during the study, lactating women.
- •Having taken another probiotic during the month prior to study entry orally or vaginally. This includes food supplements or foods supplemented with probiotics such as Actimel, Activia or similar.
- •Intake of immunomodulators or systemic corticosteroids.
- •History of alcohol or drug abuse.
- •Menopausal women.
- •Use of the IUD.
- •Use of spermicides or vaginal lubricants during the month prior to study entry.
- •Very irregular periods or low probability of going at least 18 days without menstruation (short cycles).
- •Have participated in a clinical trial during the month prior to entering the study.
- •Not being able to follow or understand study procedures. This includes not being willing to maintain sexual abstinence during the 24 hours prior to each vaginal sample collection.
- •Any other condition not compatible with the study according to the investigators
结局指标
主要结局
Colonization of L. crispatus strain in the vagina
时间窗: 0,15 or 18 days
Change in the concentration of L. crispatus strain throughout study period measured by qPCR in samples obtained with vaginal swab
Colonization of L. gasseri strain in the vagina
时间窗: 0,15 or 18 days
Change in the concentration of L. gasseri strain throughout study period measured by qPCR in samples obtained with vaginal swab
次要结局
- Vaginal microbiota composition(Day 0, 6, 12 and 15 or 18)
- Gastrointestinal symptoms(day 0, day 18)
- Vaginal colonization of L. crispatus strain(Day 0, 3, 6, 9, 12, 15)
- Vaginal colonization of L. gasseri strain(Day 0, 3, 6, 9, 12, 15)
- Perianal concentration of L. gasseri strain(Day 0, 9 and 15 or 18)
- Adverse events(18 days)
- Perianal concentration of L. crispatus strain(Day 0, 9 and 15 or 18)
- Satisfaction with the product(Day 18)
- Vaginal pH(Day 0, 3, 6, 9, 12, 15, 18)