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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-28

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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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 .

Conditions

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Stunting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intervention group given fortified synbiotic milk, control group given non-fortified synbiotic milk

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

fortified synbiotic milk

Intervention Type DIETARY_SUPPLEMENT

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

non-fortified synbiotic milk

100 ml non-fortified synbiotic milk containing 7 billion CFU Lactobacillus plantarum Dad13 in combination with 4 g prebiotic fructooligosaccharides

Group Type PLACEBO_COMPARATOR

non-fortified synbiotic milk

Intervention Type DIETARY_SUPPLEMENT

100 ml non-fortified synbiotic milk containing 7 billion CFU Lactobacillus plantarum Dad13 in combination with 4 g prebiotic fructooligosaccharides

Interventions

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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

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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susu synbio (synbio milk) fortified susu synbio (synbio milk) non-fortified

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes