Effect of Double Fortification (Iron and Zinc) in Synbiotic Milk to Under 5 Years Stunted Children Growth : the Efforts to Achieve Target 2 SDGs Utilizing Local Natural Resources
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes in Gut Microbiota Associated to Synbiotic Milk Treatment
研究概览
简要总结
The purpose of this study is to investigate the effects of double fortification (iron and zinc) in synbiotic milk (L.plantarum Dad13 and fructooligosaccharides) on under 5 years stunted children growth, gut microbiota composition, blood zinc and hemoglobin level, and cognitive level.
详细描述
This is a parallel, quadruple-blind, randomized controlled trial to determine the effects of double fortification (iron and zinc) in synbiotic milk (containing 7 billion CFU L.plantarum Dad13 and 4 g fructooligosaccharides) on the gut microbiota composition, body height and weight, blood zinc and hemoglobin level, and cognitive level in under 5 years stunted children subjects. The duration of the study is 4 months, including a 2-week pre test and informed consent before randomization of subjects into treatment or control group, a 12-week intervention period, and a 2-week post test after the end of intervention. During the intervention period, subjects will be instructed to take 100 ml of fortified synbiotic milk or non-fortified synbiotic milk per day. They will also be asked to document consumed milk, any unusual symptoms or side effects of treatment. Diet will be monitored via 24-h dietary recalls and SQ-FFQ before and after treatment respectively. Changes in the gut microbiota composition will be determined by measuring bacterial population levels (Bifidobacteria, Lactobacillus, Enterobacteria, Prevotella, and Bacteroides) in stool sampled collected at baseline and 12 weeks by qPCR. Metabolic markers (calprotectin, hemoglobin, and zinc level) will be measured at baseline and 12-weeks in serum and plasma using biochemical and immuno-assay. Changes in the cognitive level, height for age Z-score collected at baseline and 12 weeks using Bayley Scales of Infant Development, 2nd Edition .
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 5 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age between 2 year to 5 years
- •height per age z-score under -2 (stunting)
- •parents sign inform consent form
排除标准
- •have congenital abnormality
- •lactose intolerant
- •use antibiotic for more than 2 weeks
- •consume micronutrient supplement (especially iron and zinc) in the last 3 months
- •diagnose with chronic diseases and infection that interfere metabolism (i.e. tuberculosis, HIV, autoimmune disease, diabetes mellitus type 1)
- •suffer marasmus and/or kwashiorkor
- •not willing to continue the intervention
研究组 & 干预措施
fortified synbiotic milk
100 ml fortified (7,47 mg ferrous sulphate and 4,33 mg zinc acetate) synbiotic milk containing 7 billion CFU Lactobacillus plantarum Dad13 in combination with 4 g prebiotic fructooligosaccharides
干预措施: fortified synbiotic milk (Dietary Supplement)
non-fortified synbiotic milk
100 ml non-fortified synbiotic milk containing 7 billion CFU Lactobacillus plantarum Dad13 in combination with 4 g prebiotic fructooligosaccharides
干预措施: non-fortified synbiotic milk (Dietary Supplement)
结局指标
主要结局
Changes in Gut Microbiota Associated to Synbiotic Milk Treatment
时间窗: 3 months
Stools samples will be collected and analyzed before and after the intervention and compared between groups (Lactobacillus, Bifidobacteria, Bacteroides, Prevotella, and Enterobacteria) using qPCR method.
次要结局
- Changes in Height per Age Z-score Associated to Synbiotic Milk Treatment(3 months)
- Changes in Hemoglobin Level Associated to Synbiotic Milk Treatment(3 months)
- Changes in Blood Zinc Level Associated to Synbiotic Milk Treatment(3 months)
- Changes in Calprotectin Level Associated to Synbiotic Milk Treatment(3 months)
- Changes in Psychomotor Level Associated to Synbiotic Milk Treatment(3 months)
- Changes in Cognitive Level Associated to Synbiotic Milk Treatment(3 months)
研究者
DR.Siti Helmyati, DCN, M.Kes
DR.
Gadjah Mada University
