Clinical trial NCT03495401: Effect of Double Fortification (Iron and Zinc) in Synbiotic Milk to Under 5 Years Stunted Children Growth
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stunting
Lead sponsor: Gadjah Mada University
Sponsor class: OTHER
First posted: 2018-04-12
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group given fortified synbiotic milk, control group given non-fortified synbiotic milk
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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 .

Eligibility criteria: Inclusion Criteria:

* age between 2 year to 5 years
* height per age z-score under -2 (stunting)
* parents sign inform consent form

Exclusion Criteria:

* 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

Primary outcomes:
measure: Changes in Gut Microbiota Associated to Synbiotic Milk Treatment
timeFrame: 3 months
Secondary outcomes:
measure: Changes in Height per Age Z-score Associated to Synbiotic Milk Treatment
timeFrame: 3 months
measure: Changes in Hemoglobin Level Associated to Synbiotic Milk Treatment
timeFrame: 3 months
measure: Changes in Calprotectin Level Associated to Synbiotic Milk Treatment
timeFrame: 3 months
measure: Changes in Blood Zinc Level Associated to Synbiotic Milk Treatment
timeFrame: 3 months
measure: Changes in Cognitive Level Associated to Synbiotic Milk Treatment
timeFrame: 3 months
measure: Changes in Psychomotor Level Associated to Synbiotic Milk Treatment
timeFrame: 3 months
Other outcomes:
Locations:
city: Sleman
country: Indonesia
facility: Universitas Gadjah Mada
state: D.I.Yogyakarta
Study officials:
affiliation: Gadjah Mada University
name: Siti Helmyati, DR.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gadjah Mada University
name: Lily A. Lestari, DR.
role: PRINCIPAL_INVESTIGATOR
References: