Safety and Efficacy of Racecadotril in the Treatment of Acute Watery Diarrhea in Children: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Duration of diarrhea
研究概览
简要总结
Acute watery diarrhea is a common cause of illness and hospitalization in children under five years of age, particularly in developing countries. The mainstay of treatment is oral rehydration therapy, which prevents dehydration but does not reduce stool frequency or duration of diarrhea. Persistent diarrhea often leads to repeated hospital visits and increased healthcare burden.
This randomized controlled trial was conducted to evaluate the safety and efficacy of racecadotril as an adjunct to standard oral rehydration therapy in children aged 3 months to 5 years hospitalized with acute watery diarrhea. Participants were randomly assigned to receive either racecadotril in addition to standard therapy or placebo with standard therapy.
The primary outcomes assessed were reduction in stool frequency and improvement in stool consistency, along with duration of hospital stay. The study aimed to determine whether racecadotril provides additional clinical benefit when used alongside standard treatment in pediatric acute watery diarrhe
详细描述
Acute watery diarrhea is a leading cause of morbidity and hospitalization among children under five years of age. Although oral rehydration therapy (ORT) remains the cornerstone of management, it does not reduce stool output, frequency, or duration of diarrhea. Racecadotril is an antisecretory agent that reduces intestinal fluid secretion without affecting gastrointestinal motility and has been shown to be safe in pediatric populations.
This study was a single-center, randomized, placebo-controlled clinical trial conducted in the Pediatric Department of Punjab Rangers Teaching Hospital, Lahore. Children aged 3 months to 5 years of either gender presenting with acute watery diarrhea were enrolled after obtaining informed consent from parents or guardians. Acute diarrhea was defined as the passage of three or more watery stools within 24 hours with a duration of less than 72 hours.
Participants were randomized using a lottery method into two groups. The intervention group received racecadotril at a dose of 1.5 mg/kg three times daily as an adjunct to standard oral rehydration therapy and intravenous fluids when indicated. The control group received placebo along with the same standard therapy. The study was conducted under single-blind conditions.
Children with severe dehydration, chronic diarrhea, blood or mucus in stools, age below 3 months, or significant comorbidities were excluded. Clinical outcomes were assessed by monitoring stool frequency, stool consistency, and duration of hospital stay.
The study was conducted over a six-month period from June 2025 to November 2025. Ethical approval was obtained from the Ethical Committee of Punjab Rangers Teaching Hospital, Lahore. Data were analyzed using SPSS software, with results expressed as means, standard deviations, frequencies, and percentages.
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)
盲法说明
This was a single-blind study in which participants were unaware of treatment allocation.
入排标准
- 年龄范围
- 3 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 3 months to 5 years Diagnosis of acute watery diarrhea Duration of illness ≤ 72 hours Written informed consent obtained from parents or legal guardians
排除标准
- •Chronic diarrhea Severe malnutrition Severe dehydration requiring intensive care Known hypersensitivity to racecadotril Presence of serious underlying systemic illness Patient with bloody mucus containing diarrhea
研究组 & 干预措施
Racecadotril plus Standard Therapy
Participants received racecadotril in addition to standard therapy, including oral rehydration therapy and intravenous fluids when clinically indicated.
干预措施: Racecadotril (Drug)
Placebo plus Standard Therapy
Participants received placebo along with standard therapy, including oral rehydration therapy and intravenous fluids when clinically indicated.
干预措施: Placebo (Other)
结局指标
主要结局
Duration of diarrhea
时间窗: Up to 72 hours after initiation of treatment
Time from initiation of treatment until passage of the last unformed stool.
Reduction in stool frequency
时间窗: Within 12 hours of treatment initiation
Change in the number of watery stools per day after initiation of treatment.
次要结局
未报告次要终点
研究者
Own Abbas
Own Abbas
Punjab Rangers Teaching Hospital Lahore