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临床试验/CTRI/2024/02/062669
CTRI/2024/02/062669尚未招募4 期

Comparative study on clinical efficacy of Bacillus Clausii ( Bifilac Clausi ) in the management of acute diarrhoea in children as an add on therapy with standard therapy- A randomized control study

Tablets India Limited1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年2月26日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
90
试验地点
1
主要终点
Frequency of loose stools

研究概览

简要总结

Acute diarrhoea is defined as a change in the consistency of stool leading to loose or liquid stools and/or an increase in the frequency of evacuations to three or more in 24 hours with or without fever or vomiting lasting 7 days or less. Diarrhoea is usually a symptom of an infection in the intestinal tract, which can be caused by a variety of bacterial, viral and parasitic organisms. It is the most common cause of mortality among under five children in developing countries. Infection is spread through contaminated food or drinking water or from person-to-person as a result of poor hygiene. Diarrhoea due to infection is widespread throughout developing countries. In developing countries, children under 5 years of age experience on average three episodes of diarrhoea every year. Repeated episodes of diarrhoea in children can result in long-term deleterious effects on nutritional status, possibly due to intestinal damage. Each episode deprives the child from the basic nutrition necessary for growth. The management of acute diarrhoea consists of the replacement of lost fluid and electrolytes with oral rehydration to reduce the complications like dehydration, electrolyte disturbances and metabolic acidosis.

Probiotics are live microbial feed supplements that beneficially affect the host by improving the microbial balance. They are commonly used in the treatment and prevention of acute diarrhoea. Out of many probiotics available, Bacillus clausii is found to be beneficial in reducing intensity and duration of diarrhea in children aged 6 months to 5 years.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
6.00 Month(s) 至 5.00 Year(s)(—)
性别
All

入选标准

  • Children aged between 6 months to 5 years old with care of diarrhoea less than 3 days.

排除标准

  • Children with severe dehydration Presence of systemic infections Children with known immunocompromising morbidities Children with severe acute malnutrition, Children with chronic or severe respiratory, cardiovascular, central nervous system, endocrine and other gastrointestinal disorders on clinical examination.

结局指标

主要结局

Frequency of loose stools

时间窗: 24 hours and 72 hours and 120 hours

次要结局

  • Changes in stool consistency(24 hours & 72 hours & 120 hours)

研究者

申办方类型
Pharmaceutical industry-Indian
责任方
Principal Investigator
主要研究者

Dr K Karthika

Government Kilpauk Medical College

研究点 (1)

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