NCT02139839已完成早期 1 期
A Single-Center Exploratory Study to Evaluate the Effects of the Probiotics L. Rhamnosus GR-1 and L. Reuteri RC-14 on Subjects With Intermediate Nugent Scores
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change from baseline Nugent Score (arbitrary units) after treatment versus Change from baseline Nugent Score after placebo
研究概览
简要总结
The purpose of this study was to determine whether L. rhamnosus GR-1 and L. reuteri RC-14 delivered via capsules to the vagina of post-menopausal women over a three day course of treatment can restore and maintain a lactobacilli-dominated microbiota. Exploratory analysis of microbial ecology, human microarrays and multiplex immunological assessments are included to characterize potential effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Willing and able to read, understand, and sign the Informed Consent Form (ICF);
- •Post-menopausal females between the ages of 40 and 80 years old (subjects who have not had a menstrual period for the last 12 months);
- •Currently in a mutually monogamous sexual relationship or not sexually active;
- •Agree to be sexually abstinent 72 hours prior to each study visit. Also, agree to refrain from intercourse for 48 hours after treatment administration;
- •Agree to abstain from the use of any other intravaginal product (e.g. gels, foams, lubricants, douches, etc.) throughout the study period, from the time of screening until Day 47;
- •Willing and capable of following all study instructions; and
- •Good general health.
排除标准
- •Use of vaginal lubricants, or any products applied vaginally within three months prior to Visit 1and throughout the duration of study participation;
- •A history or currently undergoing immunosuppressive drug therapy, chemotherapy, or radiation therapy;
- •A medical condition which might compromise immune system functions (such as cancer, leucopenia, HIV-positive, or organ transplant);
- •Antibiotics and/or antifungal medication use within the last four (4) weeks;
- •Oral probiotic supplement use within 3 months prior to Visit 1 and throughout the duration of the study;
- •Significant changes in diet during the course of the study based on self-report;
- •Induced menopause due to surgical or medical interventions, such as bilateral oophorectomy, hysterectomy, chemotherapy or radiation treatment;
- •Currently undergoing local or systemic estrogen therapy who are not willing to alter therapy during the course of the study;
- •A Nugent Score of 0 - 3 or greater than 6;
- •History of drug or alcohol abuse;
- •Currently diagnosed with or being treated for a genital infection or urinary tract infection;
- •Individuals with a sexually transmitted disease (self-reported or detected by the Principal Investigator);
- •At enrollment, have any social or medical condition, or psychiatric illness that, in the opinion of the Investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives;
- •Participation in a clinical trial involving an investigational product/device within the past three months; subjects who are scheduled to participate in another clinical study concurrently; and
- •Known intolerance or allergy to L. rhamnosus GR-1® or L. reuteri RC-14® or to any product excipients.
研究组 & 干预措施
Gelatin pill first
Placebo Comparator
干预措施: Lactobacillus capsules (Other)
Gelatin pill first
Placebo Comparator
干预措施: Placebo gelatin pill (Drug)
Lactobacillus capsules first
Experimental
干预措施: Lactobacillus capsules (Other)
Lactobacillus capsules first
Experimental
干预措施: Placebo gelatin pill (Drug)
结局指标
主要结局
Change from baseline Nugent Score (arbitrary units) after treatment versus Change from baseline Nugent Score after placebo
时间窗: Baseline Days 15 & 36, post treatment/control Days 19 & 40
Determine whether L. rhamnosus GR-1 and L. reuteri RC-14 delivered via capsules to the vagina of post-menopausal women over a three day course of treatment can restore and maintain a lactobacilli-dominated microbiota for one week as measured by a decrease in the Nugent Scores from an intermediate score (4 - 6) at baseline to a normal score (0 - 3) following treatment compared to a placebo.
次要结局
- Percent Lactobacilli abundance(Untreated (Days 1, 5, & 15), Baseline Treatment I (Days15), Treatment I (Days 19 & 26), Baseline Treatment II (Day 36), Treatment II (Days 40 & 47))
- Change in presence of metabolites(Untreated (Days 1, 5, & 15), Baseline Treatment I (Days15), Treatment I (Days 19 & 26), Baseline Treatment II (Day 36), Treatment II (Days 40 & 47))
- Change in cytokine/chemokine levels(Untreated (Days 1, 5, & 15), Baseline Treatment I (Days15), Treatment I (Days 19 & 26), Baseline Treatment II (Day 36), Treatment II (Days 40 & 47))
- Change in global host gene expression(Untreated (Days 1, 5, & 15), Baseline Treatment I (Days15), Treatment I (Days 19 & 26), Baseline Treatment II (Day 36), Treatment II (Days 40 & 47))
- Change in self-reported vaginal symptoms(Untreated (Days 1, 5, & 15), Baseline Treatment I (Days15), Treatment I (Days 19 & 26), Baseline Treatment II (Day 36), Treatment II (Days 40 & 47))
研究者
研究点 (1)
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