StuntingNCT03495401
Effect of Double Fortification (Iron and Zinc) in Synbiotic Milk to Under 5 Years Stunted Children Growth
A study testing fortified synbiotic milk and non-fortified synbiotic milk in people with Stunting, run by Gadjah Mada University at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Stunting
- What is being tested?
- fortified synbiotic milk and non-fortified synbiotic milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIndonesia
- Study dates
- 28 Apr 2018to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age between 2 year to 5 years
- height per age z-score under -2 (stunting)
- parents sign inform consent form
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Universitas Gadjah Mada
Sleman, D.I.Yogyakarta, 55281
Siti Helmyati, DR.
About this study
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
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.
Read the 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 .
- Conditions
- Stunting
- Being tested
- fortified synbiotic milk, non-fortified synbiotic milk
- Medical subject headings
- Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fortified synbiotic milkDietary supplement
Also called susu synbio (synbio milk) fortified
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 milkDietary supplement
Also called susu synbio (synbio milk) non-fortified
100 ml non-fortified synbiotic milk containing 7 billion CFU Lactobacillus plantarum Dad13 in combination with 4 g prebiotic fructooligosaccharides
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: fortified synbiotic milk |
| 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 Receives: Dietary Supplement: non-fortified synbiotic milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Gut Microbiota Associated to Synbiotic Milk Treatment
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.
Measured: 3 months
Secondary outcomes (6)
Changes in Height per Age Z-score Associated to Synbiotic Milk Treatment
Height data will be collected and analyzed before and after the intervention and compared between groups
Measured: 3 months
Changes in Hemoglobin Level Associated to Synbiotic Milk Treatment
Hemoglobin data will be collected and analyzed before and after the intervention and compared between groups using biochemistry method
Measured: 3 months
Changes in Calprotectin Level Associated to Synbiotic Milk Treatment
Calprotectin data will be collected and analyzed before and after the intervention and compared between groups using immuno-assay method
Measured: 3 months
Changes in Blood Zinc Level Associated to Synbiotic Milk Treatment
Calprotectin data will be collected and analyzed before and after the intervention and compared between groups using Atomic Absorbance Spectrophotometry method
Measured: 3 months
Changes in Cognitive Level Associated to Synbiotic Milk Treatment
Cognitive level will be collected and analyzed before and after the intervention and compared between groups using Bayley Scales of Infant Development, 2nd Edition (BSID). This part of BSID evaluation, which yields a score called the mental development index, evaluates several types of abilities: sensory/perceptual acuities, discriminations, and response; acquisition of object constancy; memory learning and problem solving; vocalization and beginning of verbal communication; basis of abstract thinking; habituation; mental mapping; complex language; and mathematical concept formation. Total score from test will determine mental development index of children : accelerated performance (score ≥85), within normal limit (score 70-84), mildly delayed performance (score 55-69), and significantly delayed performance (score <55).
Measured: 3 months
Changes in Psychomotor Level Associated to Synbiotic Milk Treatment
Psychomotor data will be collected and analyzed before and after the intervention and compared between groups using Bayley Scales of Infant Development, 2nd Edition (BSID). This part of the BSID assesses the degree of body control, large muscle coordination, finer manipulatory skills of the hands and fingers, dynamic movement, postural imitation, and the ability to recognize objects by sense of touch (stereognosis). Total score from test will determine motor development index of children : accelerated performance (score ≥85), within normal limit (score 70-84), mildly delayed performance (score 55-69), and significantly delayed performance (score <55).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start28 Apr 2018
- Primary completion30 Sep 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StuntingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group given fortified synbiotic milk, control group given non-fortified synbiotic milk
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR.Siti Helmyati, DCN, M.Kes, Gadjah Mada University
- Investigators
- Siti Helmyati, DR., Principal investigator, Gadjah Mada UniversityLily A. Lestari, DR., Principal investigator, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495401
- Sponsor's protocol ID
- KE/FK/0640/EC/2017
- Status last verified
- Apr 2018
- First submitted
- 4 Mar 2018
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03495401
- Acronym / sponsor ID
- KE/FK/0640/EC/2017
- Conditions
- Stunting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Study start
- 28 Apr 2018 (actual)
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 12 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention group given fortified synbiotic milk, control group given non-fortified synbiotic milk
| Arm | Type | Receives |
|---|---|---|
| fortified synbiotic milk | Experimental | Dietary Supplement: fortified synbiotic milk100 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 | Placebo comparator | Dietary Supplement: non-fortified synbiotic milk100 ml non-fortified synbiotic milk containing 7 billion CFU Lactobacillus plantarum Dad13 in combination with 4 g prebiotic fructooligosaccharides |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- age between 2 year to 5 years
- height per age z-score under -2 (stunting)
- parents sign inform consent form
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fortified synbiotic milkAlso: susu synbio (synbio milk) fortified100 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 | Dietary supplement | fortified synbiotic milk |
| non-fortified synbiotic milkAlso: susu synbio (synbio milk) non-fortified100 ml non-fortified synbiotic milk containing 7 billion CFU Lactobacillus plantarum Dad13 in combination with 4 g prebiotic fructooligosaccharides | Dietary supplement | non-fortified synbiotic milk |
Primary outcome
Changes in Gut Microbiota Associated to Synbiotic Milk Treatment
Time frame: 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.
6 secondary outcomes
Changes in Height per Age Z-score Associated to Synbiotic Milk Treatment
Time frame: 3 months
Changes in Hemoglobin Level Associated to Synbiotic Milk Treatment
Time frame: 3 months
Changes in Calprotectin 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Stunting
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
RecruitingObservational study
Study of Proteus Syndrome and Related Congenital Disorders
Proteus Syndrome, PIK3CA Related Overgrowth Spectrum
Active, not recruitingPhase 2
Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan
Environmental Enteric Dysfunction (EED), Stunting
Recruiting
STV Analysis Versus Visual Evaluation of Cardiotocography in FGR
Fetal Growth Retardation
RecruitingPhase 2
Statin Intervention for Severe Early-Onset Placental Insufficiency. (STATIN-PRE Trial)
Preeclampsia (PE), Intrauterine Growth Restriction (IUGR)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siti Helmyati, DR. principal investigator
Gadjah Mada University
Lily A. Lestari, DR. principal investigator
Gadjah Mada University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fortified synbiotic milk and non-fortified synbiotic milk in people with Stunting, run by Gadjah Mada University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Siti Helmyati, DR. (+62274547775, siti.helmyati@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Gut Microbiota Associated to Synbiotic Milk Treatment (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2018.