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临床试验/NCT03495401
NCT03495401Unknown不适用

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

Gadjah Mada University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年4月28日最近更新:
适应症
干预措施

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

Experimental

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

Placebo Comparator

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

发起方
Gadjah Mada University
申办方类型
Other
责任方
Principal Investigator
主要研究者

DR.Siti Helmyati, DCN, M.Kes

DR.

Gadjah Mada University

研究点 (1)

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