"Comparison of efficacy and safety of synbiotic versus probiotic in the treatment of acute gastroenteritis in hospitalised children: A prospective, randomized, open-label, 12-day study."
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- compare the reduction in frequency and duration of diarrhea after administration of synbiotic and probiotic
研究概览
简要总结
This prospective, randomized, open-label study aims to compare the efficacy, safety, and tolerability of synbiotics versus probiotics as adjunctive therapy in children aged 6 months to 12 years hospitalized with acute gastroenteritis. Diarrheal illness is a significant cause of morbidity and mortality among young children. Although probiotics have shown moderate benefits in reducing diarrhea duration, synbiotics—combinations of probiotics and prebiotics—are thought to have superior effects by enhancing gut microflora, improving immunity, and reducing inflammation.
The study will enroll 166 children divided into two groups: one receiving synbiotics with standard therapy and the other probiotics with standard therapy (oral rehydration and zinc supplementation). Primary objectives include comparing reductions in diarrhea frequency and duration, with secondary assessment of stool consistency and adverse effects. Data will be analyzed statistically, and ethical guidelines will be strictly followed.
The study expects that synbiotics will result in faster recovery and better outcomes than probiotics alone, potentially offering an effective strategy for managing acute gastroenteritis in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Month(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children with acute diarrhea admitted to in patient department & showing signs of dehydration (less than 14 days duration) Parents willing to give written informed consent.
排除标准
- •Children with persistent/chronic diarrhea
- •Children with severe malnutrition
- •Children having respiratory/systemic infection
- •Subjects who participated in any investigational drug within 30 days prior to study screening
- •Children with known hypersensitivity for synbiotic or probiotics
- •Children with chronic systemic illness
- •Parents not willing to give written inform consent.
结局指标
主要结局
compare the reduction in frequency and duration of diarrhea after administration of synbiotic and probiotic
时间窗: 0, 5th and 12th day
次要结局
- 1) To assess the effects on consistency of stool(2) To evaluate adverse drug reactions of Synbiotic and Probiotic)
研究者
Vinesh choudhary
Indira Gandhi Government Medical College