Effectiveness and Efficacy of Zinc With Probiotics for the Treatment of Acute Diarrhea in Young Children
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 256
- 试验地点
- 2
- 主要终点
- Period of diarrhea in hours
研究概览
简要总结
Diarrheal disease is one of the major causes of morbidity and mortality in children under five. Disease is treated symptomatically with oral rehydration (ORS) as a basic measure. In children with severe zinc deficiency, diarrhea is common and responds quickly to zinc supplementation. Zinc supplementation may also helpful in diarrheal children without zinc deficiency. Effectiveness of zinc was proven in developing countries but was not in Europe. Objective of our study is to assess whether zinc supplementation given with probiotics and ORS is effective in acute diarrhea in children in Poland.
详细描述
A double-blind, placebo controlled trial
- We are going to enroll 256 patients (aged > 1 months to 36 months) with acute watery diarrhea defined as 3 d or more watery stools per day lasting not less than 1 day and not longer than 5 days.
Exclusion criteria:
severe dehydration (> 10%) Coexisting severe infection (E.g. Sepsis, pneumonia, meningitis) Immune deficiency Chronic digestive tract disease (e.g. celiac diseases, food allergy) Therapy with Antibiotics
Patients will be randomly assigned to 2 groups to receive: (a) zinc sulfate 10-20 mg/day for 10 days plus probiotics for 5 days (b) placebo for 10 days plus probiotics for 5 days. Patients will be observed in ambulatory or in the hospital (if necessary) and followed up for 15 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Month 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 1-36 months
- •Acute diarrhea defined as 3 or more watery stools per day
- •Informed consent (parents)
排除标准
- •Severe dehydration (> 10%)
- •Coexisting severe infection (e.g. sepsis, pneumonia, meningitis)
- •Immune deficiency
- •Chronic digestive tract disease (e.g. celiac diseases, food allergy)
- •Antibiotic therapy
研究组 & 干预措施
Zinc sulfate
Children in active treatment group will be given zinc sulfate 10-20 mg per day orally plus probiotics
干预措施: Zinc Sulfate (Drug)
Placebo
Children will be given placebo plus probiotics
干预措施: Zinc Sulfate (Drug)
结局指标
主要结局
Period of diarrhea in hours
时间窗: 15 days
The primary endpoint of our study is the time of acute diarrhea
次要结局
- number of stools in consequent days(15 days)