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临床试验/NCT06429358
NCT06429358已完成不适用

The Role of Probiotics in Preventing Recurrent Urinary Tract Infections in Pregnant Women: A Randomized Control Trial

Frontier Medical and Dental College, Abbotabad1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年6月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Urinary Detailed Report Values

研究概览

简要总结

Urinary tract infections (UTIs) are a significant public health problem affecting more than 150 million people worldwide and causing a significant economic impact of approximately US$ 6 billion annually. It is one of the most common infectious diseases after upper respiratory tract infections. More than 50% of women and at least 12% of men will be affected by urinary tract infections in their lifetime. The probiotic supplement was delivered as easy-to-swallow capsules specifically prepared to maintain the viability and stability of the Lactobacillus rhamnosus GG strain throughout the research period. Participants were told to take the probiotic supplement with water to maximise absorption and efficiency, ideally after meals.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women aged 18-40 year
  • History of recurrent urinary tract infections (two or more episodes in the past year).
  • Singleton pregnancy.

排除标准

  • Multiple gestations.
  • History of preterm labor.
  • Chronic medical conditions (e.g., diabetes mellitus, immunodeficiency disorders).
  • Use of antibiotics or probiotics within the past month.

结局指标

主要结局

Urinary Detailed Report Values

时间窗: second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.

The test was performed to determine levels of neutrophils

pH

时间窗: second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.

Urinary pH values were measured

Urine Culture

时间窗: second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.

Urine Culture: Urine samples were collected aseptically prior to and after intervention and cultured to detect bacterial pathogens linked with urinary tract infections. This assessment was carried out at two distinct time points: Pre-Intervention: Before beginning the probiotic intervention, baseline urine samples were taken to detect any existing bacterial illnesses and create a point of comparison. Post-Intervention: After the intervention period, individuals supplied an additional urine sample for culture investigation. This post-intervention evaluation sought to establish any changes in the prevalence of bacterial pathogens, particularly those known to cause urinary tract infection

Leukocytes:

时间窗: second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.

leukocytes in urine were evaluated

Nitrites:

时间窗: second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.

presence of nitrites in urine before and after intervention was investigated

次要结局

未报告次要终点

研究者

发起方
Frontier Medical and Dental College, Abbotabad
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Saif ur Rehman

Professor

Frontier Medical and Dental College, Abbotabad

研究点 (1)

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