Randomized Clinical Trial on the Safety and Efficacy of Lactobacillus Reuteri DSM 16666/ATCC 55845 & Lactobacillus Reuteri DSM 17938 for Treatment of Pregnant Women With Asymptomatic Bacteriuria or Uncomplicated Acute Cystitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Clinical and/or Bacteriological cure
研究概览
简要总结
Prevalence of uro-genital infections during pregnancy move between 7% to 12% in developed countries, meanwhile in developing countries this figure moved between 14% and until 55%, such is the case of Mexico. Meanwhile use of antibiotics for 3 to 7 days had established as a standard of care, the use of non-antibiotic therapy, such as cranberry powder or probiotics for prevention/treatment of this conditions is scarce. Randomized controlled trial aimed to evaluate the safety and efficacy of probiotic vs. antibiotics to treat pregnant women with uncomplicated cystitis or asymptomatic bacteriuria
详细描述
Randomized controlled trial, aimed to evaluate the efficacy of Lactobacillus reuteri DSM 16666/ATCC 55845 & Lactobacillus reuteri DSM 17938 for the treatment of pregnant women with asymptomatic bacteriuria or uncomplicated acute cystitis. As primary outcome we will evaluate the number of cases with clinical (symptoms severity) or bacteriological cure in pregnant women with uncomplicated cystitis or asymptomatic bacteriuria after 7 days treatment with probiotics vs. placebo. As secondary outcome we will evaluate a) rate of recurrence cases in each group; b) time to relapse; c) frequency of pyelonephritis; d) birth weight and head circumference; d) number of cases of preterm babies (less than 36 weeks of gestation); e) frequency of antibiotic as rescue treatment; f) frequency of adverse related events in each arm and g) frequency of preeclampsia. Women on active group will receive a combination of at least 5*10^8 CFU of Lactobacillus reuteri DSM 16666/ATCC 55845 & Lactobacillus reuteri DSM 17938, PAC-A and Zinc. Women in control group will receive o Amoxicillin + clavulanic acid (500 mg twice daily) for seven days in patients with negative nitrites in dipstick or oral nitrofurantoin (200mg twice per day) ror patients with positive dipstick.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomization list will by assembled by independient organization not related with participant, care provider, investigators or sponsors. eCRF will include randomization selection
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy women on the second or third trimester of pregnancy with positive urine culture according to the operational definition with or without symptoms
- •Age 18 to 40 years
- •Verbal and Written Informed Consent for participation in the study
排除标准
- •Pathologic pregnancy (different for UTI)
- •No supplementation of probiotics 2 weeks before study start or during the study period.
- •Antibiotic therapy within last 2 weeks before randomization
- •Known allergies towards the ingredients of the experimental product
- •Inability to comprehend the study protocol
- •Systemic diseases
- •Multiple pregnancy
研究组 & 干预措施
Probiotic
5*10^8 CFU of Lactobacillus reuteri DSM 16666/ATCC 55845 & Lactobacillus reuteri DSM 17938, PAC-A and Zinc
干预措施: Probiotics (Dietary Supplement)
Antibiotic
Amoxicillin + clavulanic acid (500 mg twice daily) for seven days in patients with negative nitrites in dipstick or oral nitrofurantoin (200mg twice per day) for patients with positive nitrates in dipstick
干预措施: Antibiotics (Drug)
结局指标
主要结局
Clinical and/or Bacteriological cure
时间窗: 14 days
Number of cases with improvement of symptoms severity and/or urinary culture during the first seven days of treatment
次要结局
- Frequency of preterm babies(6 months)
- Recurrence rate(6 months)
- Antibiotic rescue(6 months)
- Time to relapse(6 months)
- Frequency of pyelonephritis(6 months)
- Adverse events(14 days)
研究者
Pedro Gutierrez Castrellon
Head of Research
Innovacion y Desarrollo de Estrategias en Salud