NCT00752193已完成不适用
Safety and Efficacy of a Vaginally Administered Probiotic Lactobacilli Delivery System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 206
- 试验地点
- 2
- 主要终点
- The proposed research project aims at the development of a vaginal probiotic delivery system to restore and to maintain the vaginal microflora
研究概览
简要总结
The purpose of this study is to assess the safety and the efficacy of vaginally administered probiotic lactobacilli in combination with antibiotic therapy (metronidazole) in women with microbiologically defined bacterial vaginosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Untreated Bacterial Vaginosis (BV) (asymptomatic or symptomatic) as diagnosed during the screening visit using Amsel criteria.
- •Otherwise healthy? pre-menopausal women between 18-50 years of age at date of screening.
- •Regular menstrual cycles (21-35 days) or amenorrheic for at least 3 months due to use of a long acting progestin or continuous use of oral contraceptives.
- •Subject is willing to insert vaginal applicators.
- •Subject is willing to be asked questions about personal medical health and sexual history
- •Normal Pap smear collected at the screening visit? If a subject's Visit 0 Pap smear result is any of the following, the person is ineligible for participation: ASC-US (atypical squamous cells of undetermined significance), AGC (atypical glandular cells), ASC-H (atypical squamous cells, cannot r/o high grade lesion), LSIL (low grade squamous intraepithelial lesions), HSIL (high grade squamous intraepithelial lesions), adenocarcinoma in situ, adenocarcinoma, squamous cell carcinoma in situ, squamous cell carcinoma or inadequate sample
- •Agree to be sexually abstinent 48 hours prior to Visit 1 (enrollment) until 48 hours after application of the study product and a second time after visit
- •Agree to abstain from the use of any other intravaginal product (i.e., contraceptive creams, gels, foams, sponges, lubricants, douches, etc.) throughout the trial period.
- •Agree to use an adequate method of birth control for the duration of the study to avoid pregnancy. Acceptable methods include a history of tubal ligation, male partner with a vasectomy, a steroidal contraceptive (oral, patch, injectable or implantable), IUD (Paragard or Mirena), condoms or abstinence.
- •Subject must have access to functioning refrigerator.
排除标准
- •Urogenital infection at screening or within the 21 days prior to screening. This includes urinary tract infection, Trichomonas vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis or Treponema pallidum. Subjects may be re-screened at least 21 days after the respective antibiotic or antifungal therapies have been completed.
- •History of recurrent genital herpes.
- •Diagnosis of N. gonorrhoeae, C. trachomatis, T. pallidum or T. vaginalis on two or more occasions during the six months prior to screening.
- •Pregnancy or within 2 months of last pregnancy (all subjects will have a urine pregnancy test prior to enrollment).
- •Lactation.
- •Vaginal or systemic antibiotic or antifungal therapy within 21 days of the Screening visit or within 4 months of Enrollment visit.
- •Investigational drug use within 4 months or 10 half-lives of the drug, whichever is longer, of enrollment visit. Planned investigational drug use while participating in this study.
- •Menopause.
- •IUD insertion or removal within the last 3 months.
- •Pelvic surgery within the last 3 months.
- •Cervical cryotherapy or cervical laser within the last 3 months.
- •Use of a NuvaRing® within 3 days of the screening visit or during the course of the study.
- •New long-acting treatments (e.g. depot formulation including medroxyprogesterone acetate (DMPA) form of hormonal birth control). Subjects may be enrolled if stable (> 3 months) on existing therapy as determined by the Principal Investigator.
- •Diabetes or other significant disease or acute illness that in the Investigator's assessment could complicate the evaluation.
- •Known HIV infection or positive HIV test at screening.
- •Immunosuppressive drug within 4 months.
- •Previous participation in a L. crispatus clinical study.
- •Colposcopic findings at the enrollment visit involving significant deep disruption of the epithelium.
- •Known allergy to any component (skim milk,...) of the drug or to latex (condoms).
- •Unavailable for follow-up visits.
- •History of drug or alcohol abuse.
- •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.
结局指标
主要结局
The proposed research project aims at the development of a vaginal probiotic delivery system to restore and to maintain the vaginal microflora
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Safety and efficacy of putative vaginal probiotics in healthy womeHealthy femaleISRCTN17618579Tervisetehnoloogiate Arenduskeskus AS (Competence Centre on Health Technologies)50
尚未招募
Unknown
The effect of vaginal probiotic products in eliminating Human PapillomavirusIRCT20130812014333N200Kermanshah University of Medical Sciences54
已完成
不适用
Effect of vaginal probiotic on bacterial vaginosis and vaginal candidiasisCondition 1: vulvitis and vulvovaginal candida. Condition 2: bacterial vaginosise.Candidiasis of vulva and vaginainflammation of vagina and vulvaIRCT2014050617603N1Vice chancellor for Research, Shiraz University of Medical Sciences140
招募中
3 期
Investigating the effect of vaginal probiotics on the consequences of embryo transfer, microbial culture of the uterine cavity and vagina in infertile women undergoing embryo transfer.EndometriosisIRCT20110602006689N5Tehran University of Medical Sciences156
招募中
2 期
The Determining the effect of vaginal probiotics on perinatal outcomesPreterm spontaneous labour with term delivery.Preterm spontaneous labour with term deliveryO60.2IRCT20160523028008N30Hamedan University of Medical Sciences106