Effect of Vaginal Lactose on the Vaginal Microbiota in Women With Bacterial Vaginosis: Double-blind, Placebo-controlled Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Bacterial load after intervention
研究概览
简要总结
The aim of the study was to investigate whether the administration of a vaginal tablet containing lactose can modulate the bacterial flora of women with bacterial vaginosis (BV).
Design: Double-blind, placebo-controlled randomised trial.
Setting: Women with BV who responded to advertisements in local newspapers and on posters at the Institutions for Education in Health Science in Eastern Jutland, Denmark. These individuals were supplemented with patients enrolled at a gynaecological clinic.
Participants: Forty women with BV diagnosed through the Amsel test. By randomisation, 20 were assigned to receive lactose tablets, and 20 were assigned to receive placebo tablets.
Interventions: Twice daily application of one lactose tablet or placebo tablet for 7 days.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Active and inactive tablets were identical. The tablets were packed and labelled by the manufacturer. The key to identity was retained and was disclosed after recruiting all patients. After informed consent, eligible patients drew a closed opaque envelope from a set of envelopes numbered 1-40 and placed in random order. The envelope contained both number labels for medical data-related documents and sample vials and a closed opaque container holding tablets labelled with the sample number.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Amsel criteria positive defined as 3/4 of the following: Vaginal discharge, Fishy odor, pH>4.5 and Clue cells in a wet smear.
排除标准
- •Not able to provide written informed consent.
研究组 & 干预措施
Lactose
Lactose monohydrate 810 mg, silicon dioxide 20 mg, and magnesium stearate 14 mg
干预措施: Lactose (Dietary Supplement)
Placebo
Dextran 40 EP 671 mg, silicon dioxide 20 mg and magnesium stearate 14 mg
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Bacterial load after intervention
时间窗: 7 days
quantitative measurements with qPCR for G. vaginalis, Prevotella spp., A. vaginae, Megasphaera type 1, L. gasseri, L. crispatus, L. jensenii and L. iners after intervention
次要结局
未报告次要终点
研究者
Peter Humaidan
Professor, MD
Regionshospitalet Viborg, Skive