A Randomized, Double Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy of Supplementation with Bacillus Coagulans SNZ 1969 In Reducing Infection in Malnourished Children and To Evaluate Its Safety
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Number of episodes of gastrointestinal or respiratory tract infections during the period from day 0 to day 90
研究概览
简要总结
PROBIOTICS
Many studies are tryingto evaluate the benefits of correction of gut flora to improve immunity andgrowth parameters of children. One such method is by administration ofprobiotics. The World Health Organization defines probiotics as Live microorganismswhich when administered in adequate amounts confer a health benefit on the host.A study of Lactobacillus acidophilus conducted on malnourished childrenin India found that it can cause an increment of weight and height in relationof placebo. They also observed lower frequency of diarrhea and fever episodesin this group than in controls.
However apart from lactobacillus acidophilus there are other species oflactobacillus which are being marketed as a probiotic. One such probiotic isBacillus Coagulans, which was initially described as lactobacillussporogeneses.
It seems worthwhile to study effects of Bacilluscoagulans on risk of gastrointestinal and upper respiratory tract infection inthe at-risk population
MALNUTRITION:
Malnutrition is one of the major health problems and is associated withrecurrent infections especially in gastrointestinal and respiratory tracts andalso leads to some defects in weight, height, cognitive functions, and behavior..
HYPOTHESIS:
Therefore, we have designed this study to evaluate if administration of Bacillus coagulans SNZ 1969 has any rolein reducing infections in malnourished children and improving the wellbeing ofthe children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age 1-5years 2.Evidence of moderate malnutrition (having a weight-for-height z-score of -3.0 to less than -2.0).
排除标准
- •1.Age <1yr or >5yrs, 2.History suggestive of Chronic inflammatory bowel diseases, 3.Immunocompromised /HIV positive.
- •4.Any evidence of Malignancy.
- •5.History and clinical findings suggestive of Metabolic diseases 6.History and clinical findings suggestive of Chronic respiratory tract diseases including respiratory allergies and cystic fibrosis.
- •7.Malformations of gastrointestinal or urinary or respiratory tract on clinical or radiological findings.
- •8.History of respiratory or gastrointestinal or urinary tract surgery.
- •9.History and Clinical findings suggestive of Congenital cardiac defects.
- •10.History suggestive of challenge-proved food allergy and Food intolerance.
- •11.Normal nourished (-1 12.History of use of antibiotics or pre/pro/symbiotic or immune stimulating products in the 2 weeks before the enrolment.
结局指标
主要结局
Number of episodes of gastrointestinal or respiratory tract infections during the period from day 0 to day 90
时间窗: Number of episodes of gastrointestinal or respiratory tract infections during the period from day 0 to day 90
次要结局
- Number of children experiencing at least one episode of AGI or RTI in 30 days(day 0 to day 90)
- Number of children experiencing at least one episode of AGI or RTI in 60 days(day 0 to day 90)
- Number of children experiencing at least one episode of AGI or RTI in 90 days(day 0 to day 90)
- Number of children with vomiting episodes(day 0 to day 90)
- Number of children with diarrheal episodes(day 0 to day 90)
- Number of gastrointestinal infections lasting longer than 2 days(day 0 to day 90)
- Number of children with upper respiratory tract infection, including rhinitis, pharyngitis, sinusitis, otitis, and the common cold(day 0 to day 90)
- Number of children with lower respiratory tract infections, including pneumonia, bronchitis, and bronchiolitis(day o to day 90)
- Number of respiratory tract infections lasting longer than 3 days.(day 0 to day 90)
- Number of severe diarrhea episodes.(day o to day 90)
- Total days of illness(day 0 to day 90)
- Total Number of Days with respiratory and gastrointestinal Symptoms(day o to day 90)
- Emergency Department Medical visit if child has symptoms of gastrointestinal and respiratory tract infection(day o to day 90)
- Number of days of work lost by the parents(day 0 to day 90)
- Number of days of preschool lost by children(day o to day 90)