Effect of Double Fortification (Iron and Zinc) in Synbiotic Milk to Under 5 Years Stunted Children Growth

Primary Investigator

  • Dr. Siti Helmyati, Gadjah Mada University

Study Period

April 2018 - December 2018

Study Description

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.

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 .

Study Arms

  • Experimental: fortified synbiotic milk
  • Placebo Comparator: non-fortified synbiotic milk

Primary Outcomes

  • Changes in Gut Microbiota Associated to Synbiotic Milk Treatment [ Time Frame: 3 months ]
  • Changes in Height per Age Z-score Associated to Synbiotic Milk Treatment [ Time Frame: 3 months ] Height data will be collected and analyzed before and after the intervention and compared between groups
  • Changes in Hemoglobin Level Associated to Synbiotic Milk Treatment [ Time Frame: 3 months ]
  • Changes in Blood Zinc Level Associated to Synbiotic Milk Treatment [ Time Frame: 3 months ]
  • Changes in Cognitive Level Associated to Synbiotic Milk Treatment [ Time Frame: 3 months ]
  • Changes in Psychomotor Level Associated to Synbiotic Milk Treatment [ Time Frame: 3 months ]

Study Interventions

  • Standard Fortified Food Blends
  • Other
  • Environmental enteric dysfunction (EED)

Research Gaps

  • Effectiveness

    How well do different food compositions and interventions prevent or treat undernutrition, when implemented "on the ground"?

Study Population

100