To study the effect of L. paracasei Lpc-37 or B. lactis Bi-07 supplementation for 10 months period, on diarrheal morbidity, febrile episodes, immune function, nutritional status and gut flora in apparently normal children.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Reduction in Diarrhoea prevalence
研究概览
简要总结
Specific probiotic strains have been shown to improve, be able to reduce the incidence or shorten the duration of diarrhoea. Some strains have also been shown to reduce the risk for disease. One of the main targets of probiotics is the intestine, but health benefits are not limited to that. Selected probiotics have, among others, been shown to improve immune response providing a mechanism for health benefits not directly associated with the intestine. The intestine is the body’s largest immune organ and changes in the composition and/or activity of the intestinal microflora may be, in part, responsible for an observed change in immune response.
The current study proposal therefore aims to investigate the influence of selected probiotics*(L. paracasei* Lpc-37 or B. lactis Bi-07) on the incidence and duration of acute diarrhoea, as well as immune function, nutritional status and changes in intestinal microflora. Diarrhoeal morbidity (duration and episodes –1 year) will be collected every day recall method. Use of antibiotics and febrile episodes will also be collected.
Stool microflora (by PCR) and Immune markers like calprotectin and IgA will be done by ELISA. Blood sample will be obtained to assess micronutrient status (vit A, zinc, iron, calcium, Mg) and serum cytokines will be done by ELISA. Diarrheal pathogens will be investigated in children with diarrhea. Growth will be assessed by height weight and skin fold measurement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •children aged 3-5 years, Parents willing to add a probiotic supplement or placebo each day for 10 months will be included in the study.
排除标准
- •Children with major congenital birth deformities, acute illness at enrollment, or chronic conditions affecting food intake or metabolism, Participation in another clinical study, Infants from multiple gestation births (since only one child per family will be included in the study, incorporating a child from a multiple birth would add unnecessary burden to parents by requiring them to administer different formulas to different children), past history with surgical operation of gastrointestinal tracts, Antibiotic therapy prior to enrollment, Evidence or suspicion of clinical sepsis before randomization will be excluded from the study.
结局指标
主要结局
Reduction in Diarrhoea prevalence
时间窗: Everyday Recall
次要结局
- Effect of probiotics on weight gain and linear growth(monthly weight gain)