Effect of PreforPro® (Prebiotic and Bacteriophage) on Urinary and Vaginal Health
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- To change Nugent score in women with intermediate grade or BV
研究概览
简要总结
This study will investigate the effects of PreforPro® (prebiotic and bacteriophages (LH01-Myoviridae, LL5-Siphoviridae, T4D-Myoviridae, and LL12-Myoviridae, greater > 6.7 X 107 PFU/gram) on bacterial vaginosis.
详细描述
This is a double-blinded, placebo controlled study. Each study participant will be in the study for 90 days. During the first 28 days the participants will not take study product, and will collect samples for the study in order to act as their own controls. On day 29, participants will be randomized to intervention with either PreforPro® or placebo, which they will take once daily for the remaining 62 days. There will be a total of 5 study visits during which samples will be collected, a Quality of Life questionnaire will be completed at baseline and end of study visit.
Samples for the study are: vaginal swab, faecal sample, urine sample.
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
- Double (Participant, Investigator)
盲法说明
Neither participants nor study team will know which product the participants have been assigned. Unblinding can be requested from the pharmacy if necessary.
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
- •18-45 years old premenopausal (period within 6 months)
- •Nugent score of 4-6 (intermediate) or 7-10 (BV)
- •Have an ability to collect a clean urine sample
- •Prescription and over the counter medication unchanged for > 30 days prior to the study. -Participants who are taking medications as needed (PRN) may be included if they began PRN usage >30 days prior to baseline
- •Sexually active status of the participants can be either active or inactive
- •Participants must agree to use a medically approved method of birth control (e.g. hormonal contraceptives, intrauterine devices, vasectomy/tubal ligation, barrier methods and double-barrier method) and must have negative pregnancy test results at screening and baseline
排除标准
- •Faecal incontinence
- •History of urinary fistula, bladder or kidney stones, interstitial cystitis, or cystoscopic abnormalities that could be malignant
- •Neurogenic bladder
- •A history of currently undergoing immunosuppressive drug therapy, chemotherapy, or radiation therapy
- •Antibiotic and/or anti-fungal medication used within the last four weeks
- •Oral probiotic supplement use within 2 weeks prior the study excluding yogurt
- •Drug abuse
- •Uncontrolled psychological disorders
研究组 & 干预措施
PreforPro
Preforpro Dosage form - capsule Dosage - participants will consume one capsule per day for 2 months treatment period
干预措施: Preforpro (Drug)
Placebo
placebo will come in a capsule, which has to be consumed one capsule per day for 2 months treatment period
干预措施: Placebo (Other)
结局指标
主要结局
To change Nugent score in women with intermediate grade or BV
时间窗: 3 months
Vaginal swab is collected to determine the Nugent score, which is a The Nugent Score is a gram stain scoring system for vaginal swabs to diagnose bacterial vaginosis. Nugent scores between 7-10 is the standard diagnosis of BV and indicative of the absence of lactobacilli and a relative predominance of G. vaginalis and Mobiluncus spp. A Nugent score of 4-6 is indicative of intermediate BV. A Nugent score ≤ 3 means there is no BV.
次要结局
- Determine whether probiotics can translocate from the gastrointestinal system to genitourinary system.(3 months)
- Determine change in urogenital ATP levels.(3 months)
- Determine if the microbiota in the gut and urinary system change(3 months)
- Determine whether the bacteriophage can translocate from the gastrointestinal system to genitourinary system.(3 months)
- Determine change in vaginal cell exfoliation.(3 months)
研究者
Jeremy Burton
Principal Investigator, PhD
Lawson Health Research Institute