Effect of Lactoferrin Supplementation on Urinary Tract Infections in Infants: a Randomised, Double-blind, Placebo-controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 55
- 主要终点
- Influence of lactoferrin on Interleukin-6 and Interleukin-8.
研究概览
简要总结
The aim of the study was to evaluate the efficacy of orally administered bovine lactoferrin (bLF) on Urinary Tract Infections in neonates and infants. Fifty-five patients with urinary tract infection were randomized to receive either bLF (n = 27) or an identical placebo (n = 28) for 4 weeks. The patients were assessed clinically and laboratory.
详细描述
This study was a prospective randomized controlled trial at a single university medical center. Participants were neonates or infants with Urinary Tract Infection (UTI) admitted to the Neonatal and Infant Pathology Department of Children's University Hospital in the period from July 2015 to December 2017. The intervention was bovine lactoferrin at a dosage of 100 mg/day for a period of 4 weeks compared with placebo in a control group.
During hospital treatment, laboratory tests were performed to evaluate the activity of inflammatory markers (C-reactive protein, procalcitonin, Interleukin-6 and Interleukin-8 levels and white blood cell count).
Fifty-five patients heve been included in the study.
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)
入排标准
- 年龄范围
- 7 Days 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates and infants with symptoms of Urinary Tract Infection.
- •Active infection at enrollment, confirmed and documented in medical record.
- •Children with Urinary Tract Infection treated according to current recommendations.
排除标准
- •Unconfirmed Urinary Tract Infection.
- •Critical illness and/or hemodynamic instability.
- •Allergy or sensitivity to lactoferrin or bovine derived proteins or bovine milk.
- •Children whose parents/guardians decline to participate.
结局指标
主要结局
Influence of lactoferrin on Interleukin-6 and Interleukin-8.
时间窗: at baseline, after 5 days of treatment
Levels of Interleukin in both groups. Comparing possible change.
Effect of lactoferrin on white blood cells.
时间窗: at baseline, after 5 days of treatment
To assess the change in the number of leukocytes, neutrophils, lymphocytes, monocytes, eosinophils and basophils.
Monitoring of parameters of inflammation.
时间窗: at baseline, after 5 days of treatment
C-reactive protein and procalcitonin levels in both groups. Comparing possible change.
Effect of lactoferrin on urinary inflammatory markers.
时间窗: at baseline, after 5 days of treatment
The presence of bacteria in urine and semi-quantitative measurement of white blood cells count in urine.
次要结局
- To evaluate the efficacy of lactoferrin in the reduction of probable recurrence of Urinary Tract Infection.(1 month)
- The number of days of hospitalization.(1 month)
- Evaluation of the safety of the administration of lactoferrin by monitoring possible adverse effects.(1 month)