The Efficacy Of Probiotics Versus Zinc Versus Probiotics-Zinc Combination On Acute Diarrhea In Children: A Double Blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Diarrhea consistency
研究概览
简要总结
Background: Acute diarrhea in children is still a major health burden worldwide despite all efforts that have been made to reduce its incidence and prevalence. Children are more prone for dehydration that is the most common serious complication of acute diarrhea and can be easily avoided. Initiation of rehydration, early refeeding and giving suitable antimicrobial agents when indicated are the cornerstone for management. In addition, studies have emphasized on the role and efficacy of probiotics and zinc supplements on acute diarrhea in children. Indeed, there are a lot of studies on the role of zinc and probiotic in reducing the severity of acute diarrhea, but not many studies have compared effect of using a combination zinc with probiotics to zinc alone and probiotics alone on acute diarrhea.
Objective:To compare the effectiveness of use of probiotics only, zinc only, and combination of zinc with probiotics on the duration and consistency of diarrhea in children presented for acute gastroenteritis.
Methods: A total of 240 patients diagnosed with acute diarrhea will be divided into three groups each of 80 patients. The first group will be managed by addition of probiotics to standard treatment. The second group will be managed by addition of zinc to the standard treatment. The third group will be managed by the addition to a combination of zinc and probiotics to standard treatment. The patients will be followed to compare the effect of the given medication on the duration of diarrhea.
详细描述
This is a prospective, randomized, double blinded, clinical trial that will be conducted on children presenting with acute diarrhea in Makassed General Hospital.
Patient's level of dehydration will be assessed and a base line of frequency and consistency of diarrhea will be taken from parents'/ caregivers' history and observation. The consistency of stools will be scored according to the "Bristol Stool Chart". Also parents will be asked to sign an informed consent.
A total of 240 eligible patients will be randomized by computer-generated numbers and the sealed envelope technique will be used to divide the patients into three groups.
Group A will be composed of 80 patients. All of them will be given the standard of care (initiation of hydration and early refeeding, in addition to the use of antimicrobials in case a pathogen was identified). In addition to that, the patients in this group will receive probiotics (saccharomyces boulardii) one dose per day.
Group B which will be composed of 80 patients. All of them will be given the standard of care (initiation of hydration and early refeeding, in addition to the use of antimicrobials in case a pathogen was identified). In addition to that, the patients in this group will receive zinc (10 mg for patients less than 6 month and 20 mg for older patients) one dose per day.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 31 Days 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute diarrhea
- •Patients whose parents signed informed consent
- •Patients who have dehydration according to the World Health Organization (WHO) clinical scale
排除标准
- •Severe dehydration
- •Coexisting severe infection (e.g. sepsis, pneumonia, meningitis)
- •Immune deficiency
- •Patients whose parents refuse to provide written informed consent
- •Patients who do not comply with treatment
结局指标
主要结局
Diarrhea consistency
时间窗: Till the end of diarrhea, an average of five days
consistency of diarrhea scored according to the "Bristol Stool Chart"
次要结局
- Diarrhea duration(Till the end of diarrhea, an average of five days)
- Hospital stay(Till the end of diarrhea, an average of four days)
研究者
Mariam Rajab
Pediatrician
Makassed General Hospital