Bovine Lactoferrin in the Prevention of Antibiotic-associated Diarrhoea in Children - a Randomized Clinical Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- Occurence of antibiotic-associated diarrhoea.
研究概览
简要总结
This prospective, randomized, parallel-group, double blind, single-center study is to be conducted in the Medical University of Warsaw Public Paediatric Teaching Hospital in following departments: Department of Paediatric Gastroenterology and Nutrition, Department of Paediatrics and Nephrology, Department of Pediatric Pneumonology and Allergy, Department of Pediatrics with Medical Assessment Unit, Admissions Department. It is planned to include a total of 156 children aged between 12 months to 18 years old receiving antibiotic therapy because of acute respiratory tract infection/or urinary tract infection. The children will be randomly assigned to receive 100 mg of bovine lactoferrin or placebo twice a day orally for the whole period of antibiotic therapy. The primary efficacy parameter is occurrence of diarrhea during the antibiotic therapy and two weeks after, defined as > 3 stools a day, a watery or loose stool with/or occurrence of blood in the stool.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute respiratory or urinary infection requiring empiric antibiotic therapy.
- •antibiotic treatment started before 24 hours prior to enrollment.
- •the consent of parents or legal guardians to participate in the study
排除标准
- •severe or generalized bacterial infection
- •antibiotic therapy during the last 8 weeks
- •use of probiotic during the seven days prior to enrollment
- •immune disorders,
- •chronic disease of the gastrointestinal tract,
- •actual acute or chronic diarrhea,
- •intake of iron supplementation,
- •cows milk protein allergy
- •lack of consent of the parents or legal guardians to participate in the study.
研究组 & 干预措施
A - Lactoferrin
Bovine lactoferrin orally - 100 mg twice a day, for whole antibiotic treatment period.
干预措施: Bovine lactoferrin (Dietary Supplement)
B - Maltodextrin
Maltodextrin orally - 100 mg twice a day, for whole antibiotic treatment period.
干预措施: Maltodextrin (Dietary Supplement)
结局指标
主要结局
Occurence of antibiotic-associated diarrhoea.
时间窗: Up to 24 days after initiation of antibiotic treatment.
Occurrence of diarrhea up to 24 days after initiation of antibiotic treatment, defined as \> 3 stools a day, a watery or loose stool with/or occurrence of blood in the stool.
次要结局
- Discontinuation of antibiotic treatment due to the antibiotic - diarrhoea.(Up to 10 days after initiation of antibiotic treatment.)
- Intravenous rehydration due to the antibiotic-associated diarrhea(Up to 24 days after initiation of antibiotic treatment.)