Effect of Synbiotics on Hematological Indices of Malnourished Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Weight
研究概览
简要总结
In this study, dose related effect of synbiotics on the blood indices of severely acute malnourished (SAM) children (6-59 months) was carried out in hospitalized setting. Fifty SAM children were enrolled in a double-blind, randomized design.
详细描述
The study was done at Nutrition Rehabilitation Unit (NRU), Department of Social & Preventive Pediatrics, Mayo Hospital, Lahore, Pakistan, a Tertiary Care large urban teaching and referral hospital and was approved by human ethics Institutional Review Board (IRB) .Galacto-oligosaccharides (Oligomate) as prebiotics were procured from Yakult Pharmaceutical Industry, Japan and Resiton (lactobacillus paracasei subsp. paracasei) as probiotics were procured from MakNsons Pharmaceutical Industry, Italy. In the present study we enrolled 50 severely acute malnourished (SAM) in patients of 6-59 months of age while follow-up treatment was given at the out-patient department. We define SAM as weight-for height of less than 70% of the median, nutritional edema (Kwashiorkor), or both, mid-upper arm circumference (MUAC) of less than 11.5cm. Anthropometry protocols were followed by research standards
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 6 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In the present study we enrolled 50 severely acute malnourished (SAM) patients of 6-59 months of age while follow-up treatment was given at the out-patient department.
- •Patients having weight-for-height of less than 70% of the median, nutritional edema (Kwashiorkor), or both,
- •mid-upper arm circumference (MUAC) of less than 11.5cm
排除标准
- •Participant taking other supplements or enrolled in other studies
研究组 & 干预措施
standard therapeutic food group
The control group received standard therapeutic foods (F-75, F-100 and Plumpy'nuts)
干预措施: Standard therapeutic foods (Dietary Supplement)
therapeutic foods plus synbiotics group
the intervention group received therapeutic foods plus synbiotics containing Oligomate that was fortified in F75 at the rate of 7.5 g/L containing 4.1 g/L GOS for 1 g/100 kcal dose and at the rate of 11.5 g/L containing 6.1 g/L GOS for 1.5 g/100 kcal dose while in F100 and Plumpy'nuts it was fortified at the rate of 10 g/L containing 5.5 g/L GOS for 1 g/100 kcal dose and at the rate of 15 g/L containing 8.25 g/L GOS for 1.5 g/100 kcal dose and Resiton (Lactobacillus paracasei sbsp. paracasei) 3 billion cfu/day and 6 billion cfu/day that were mixed in different combinations.
干预措施: Therapeutic foods plus Synbiotics (Combination Product)
结局指标
主要结局
Weight
时间窗: 48 days
weight change observed in patients
Number of Stools
时间窗: 48 days
Number of stools per day
次要结局
- Complete blood count (CBC)(48 days)
- Serum albumin levels(48 days)
- serum electrolytes(48 days)
- ESR determination(48 days)
- SGPT/ ALT(48 days)
- SGOT/ AST(48 days)
- Alkaline Phosphatase(48 days)