StuntingNCT05119218
Gut Microbiota Stunted Children NTT
An observational study of Stunting, run by Bina Nusantara University at 1 site in Indonesia.
Trial summary
NTT Province is on the list of priority areas of high prevalence of stunting, Southwest Sumba, South Middle East, and Kupang district have a stunting prevalence of 36.2%, 34.5% and 48.1% respectively in 2020. Therefore, it is necessary to conduct a profile study. Read more about this study
- Who is it for?
- Ages 36 to 45 monthsHealthy volunteers can take part
- Conditions the study is for
- Stunting
- How many people
- 200 participants
- Where
- 1 siteIndonesia
- Study dates
- 2 Nov 2021to 20 Feb 2022
- How long will I take part?
- 3 Days
- Phase
- Observational
- 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 36 to 45 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: This observational study used a cross sectional design with a quantitative approach. The cross-sectional research design is a research conducted at one time and one time to find the relationship between the independent variable (risk factor) and the dependent variable (effect) as baseline data
Who may be able to join
- Anthropometric measurements of stunting were measured based on the parameters of length/height according to age compared to the 2005 WHO anthropometric standards and the Indonesian Ministry of Health Decree No. 1995/MENKES/SK/XII/2010.
Who cannot join
- criteria thats makes subject appropiate, like more than 5 years old, not live in sampling area, unhealthy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gut Microbiota Profile, SCFA, Gut Integrity, Parasite Infection, Hygiene Practice and Cognitive Score on Stunted Children in East Nusa Tenggara
NTT Province is on the list of priority areas of high prevalence of stunting, Southwest Sumba, South Middle East, and Kupang district have a stunting prevalence of 36.2%, 34.5% and 48.1% respectively in 2020. Therefore, it is necessary to conduct a profile study. microbiota, SCFA, gastrointestinal integrity, parasites, hygiene practice, and cognition in stunting and healthy toddlers in the province of East Nusa Tenggara,
Read the detailed description
Stunting indicates a public health problem because it is associated with an increased risk of morbidity and mortality, decreased motor and mental function development, and reduced physical capacity. Stunting is a chronic nutritional deficiency condition that affects the growth and development, and intelligence of children. Lack of nutrients can cause intestinal microbiota dysbiosis where this will reduce the metabolism of short chain fatty acids (SCFA) which will affect the absorption of nutrients in the small intestine and cause impaired immunity, which in turn worsens stunting conditions. The composition of the gut microbiota is influenced by age, sex, geographic area and food intake. Therefore, the description of knowledge, attitudes and applications in society, especially mothers and child subjects, was also analyzed using a hygiene practice questionnaire. The aim of the study was to obtain an overview of the gut microbiota, gastrointestinal integrity, parasitic infections, hygiene practices and cognitive scores in stunting and healthy toddlers in several areas in the province of East Nusa Tenggara as a baseline study to be followed up by intervention study.
The research will be conducted for 3 (three) months in 2021/2022. The subjects involved represented 100 stunted children and 100 healthy children aged 36-45 months from each region. Determination of the sample with a sampling quota. The variables studied were the nutritional status of under five years children, characteristics of children under five (age, gender, birth weight (BBL), birth length, breast feeding history, immunization history, history of diarrhea, history of ARI (Upper Respiratory Tract Infection)), mother and family characteristics (age, education). , occupation, father's occupation, total family income), home environment and hygiene, vaccination history, gastrointestinal microbiota status, gastrointestinal integrity, parasites, hygiene practices, and cognitive scores.
- Conditions
- Stunting
- Being tested
- No Intervention
- Keywords
- stunting, Gut microbiota, toddler, SCFA, Parasite, Hygiene Practice
- Medical subject headings
- Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| Stunted subject | The population is all children under five aged 3-5 years in the stunting locus village. Subjects in this study were taken with a sampling quota of 100 stunting toddlers toddlers in each area. Receives: Other: No Intervention | |
| Normal subject | The population is all children under five aged 3-5 years in the stunting locus village. Subjects in this study were taken with a sampling quota of 100 non-stunted toddlers in each area. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
200 sample Gut Microbiota Profile descript OTU by NGS
Profile of genus microbiota observed using Next Generation Sequencing
Measured: 2 months
Secondary outcomes (5)
200 sample Short Chain Fatty Acid Profile from feses sample
microbiota metabolite profile
Measured: 1 months
200 sample Gut Integrity profile from blood sample
serum lipid binding protein, serum citrulline, serum Intestinal Fatty Acid Binding Protein (IFABP), serum Fatty Acid Binding Protein (FABP), sCD14, dan sCD163.
Measured: 2 months
200 sample immune response from blood sample
TNF, TGF, IL-10, dan sIgA
Measured: 2 months
200 data hygiene practice from quenstionare data
epidemiology data, daily hygiene practice, family data
Measured: 2 months
200 cognitive development data from coqnitive measurement
coqnitive descriptive
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start2 Nov 2021
- Primary completion30 Jan 2022
- Study completion20 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Bina Nusantara University
- Sponsor type
- University, hospital or other
- Collaborators
- Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia, Maastricht University, Universitas Airlangga, Yarsi University, Universitas Kristen Indonesia
- Responsible party
- Principal investigator, Ingrid S Surono, Bina Nusantara University
- Investigators
- Ingrid S Surono, PhD, Principal investigator, Bina Nusantara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119218
- Sponsor's protocol ID
- 332/KEP-UY/BIA/X/2021
- Status last verified
- Aug 2022
- First submitted
- 2 Nov 2021
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: planned not to be shared
Publications
Surono IS, Jalal F, Bahri S, Romulo A, Kusumo PD, Manalu E, Yusnita, Venema K. Differences in immune status and fecal SCFA between Indonesian stunted children and children with normal nutritional status. PLoS One. 2021 Jul 29;16(7):e0254300. doi: 10.1371/journal.pone.0254300. eCollection 2021.
PubMed 34324500Surono IS, Widiyanti D, Kusumo PD, Venema K. Gut microbiota profile of Indonesian stunted children and children with normal nutritional status. PLoS One. 2021 Jan 26;16(1):e0245399. doi: 10.1371/journal.pone.0245399. eCollection 2021.
PubMed 33497390Surono IS, Athiyyah AF, Venema K. Gut microbiota, SCFA and nutritional intake in stunted children in East Nusa Tenggara, Indonesia. Benef Microbes. 2025 Jul 24;16(6):647-658. doi: 10.1163/18762891-bja00090.
PubMed 40716760Surono IS, Popov I, Verbruggen S, Verhoeven J, Kusumo PD, Venema K. Gut microbiota differences in stunted and normal-lenght children aged 36-45 months in East Nusa Tenggara, Indonesia. PLoS One. 2024 Mar 29;19(3):e0299349. doi: 10.1371/journal.pone.0299349. eCollection 2024.
PubMed 38551926
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbiota Profile, SCFA, Gut Integrity, Parasite Infection, Hygiene Practice and Cognitive Score on Stunted Children in East Nusa Tenggara
- ClinicalTrials.gov ID
- NCT05119218
- Acronym / sponsor ID
- 332/KEP-UY/BIA/X/2021
- Conditions
- Stunting
- Keywords
- stunting, Gut microbiota, toddler, SCFA, Parasite, Hygiene Practice
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Bina Nusantara UniversityUniversity, hospital or other
- Collaborators
- Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia, Maastricht University, Universitas Airlangga, Yarsi University, Universitas Kristen Indonesia
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 20 Feb 2022 (actual)
- First posted
- 15 Nov 2021 (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.
NTT Province is on the list of priority areas of high prevalence of stunting, Southwest Sumba, South Middle East, and Kupang district have a stunting prevalence of 36.2%, 34.5% and 48.1% respectively in 2020. Therefore, it is necessary to conduct a profile study. microbiota, SCFA, gastrointestinal integrity, parasites, hygiene practice, and cognition in stunting and healthy toddlers in the province of East Nusa Tenggara,
Detailed description
Stunting indicates a public health problem because it is associated with an increased risk of morbidity and mortality, decreased motor and mental function development, and reduced physical capacity. Stunting is a chronic nutritional deficiency condition that affects the growth and development, and intelligence of children. Lack of nutrients can cause intestinal microbiota dysbiosis where this will reduce the metabolism of short chain fatty acids (SCFA) which will affect the absorption of nutrients in the small intestine and cause impaired immunity, which in turn worsens stunting conditions. The composition of the gut microbiota is influenced by age, sex, geographic area and food intake. Therefore, the description of knowledge, attitudes and applications in society, especially mothers and child subjects, was also analyzed using a hygiene practice questionnaire. The aim of the study was to obtain an overview of the gut microbiota, gastrointestinal integrity, parasitic infections, hygiene practices and cognitive scores in stunting and healthy toddlers in several areas in the province of East Nusa Tenggara as a baseline study to be followed up by intervention study.
The research will be conducted for 3 (three) months in 2021/2022. The subjects involved represented 100 stunted children and 100 healthy children aged 36-45 months from each region. Determination of the sample with a sampling quota. The variables studied were the nutritional status of under five years children, characteristics of children under five (age, gender, birth weight (BBL), birth length, breast feeding history, immunization history, history of diarrhea, history of ARI (Upper Respiratory Tract Infection)), mother and family characteristics (age, education). , occupation, father's occupation, total family income), home environment and hygiene, vaccination history, gastrointestinal microbiota status, gastrointestinal integrity, parasites, hygiene practices, and cognitive scores.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stunted subject | – | Other: No InterventionThe population is all children under five aged 3-5 years in the stunting locus village. Subjects in this study were taken with a sampling quota of 100 stunting toddlers toddlers in each area. |
| Normal subject | – | Other: No InterventionThe population is all children under five aged 3-5 years in the stunting locus village. Subjects in this study were taken with a sampling quota of 100 non-stunted toddlers in each area. |
Who may qualify
- Ages
- 36 to 45 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- This observational study used a cross sectional design with a quantitative approach. The cross-sectional research design is a research conducted at one time and one time to find the relationship between the independent variable (risk factor) and the dependent variable (effect) as baseline data
Key inclusion criteria (1 listed)
- Anthropometric measurements of stunting were measured based on the parameters of length/height according to age compared to the 2005 WHO anthropometric standards and the Indonesian Ministry of Health Decree No. 1995/MENKES/SK/XII/2010.
Key exclusion criteria (1 listed)
- criteria thats makes subject appropiate, like more than 5 years old, not live in sampling area, unhealthy
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 |
|---|---|---|
| No InterventionNo Intervention | Other | Normal subject, Stunted subject |
Primary outcome
200 sample Gut Microbiota Profile descript OTU by NGS
Time frame: 2 months
Profile of genus microbiota observed using Next Generation Sequencing
5 secondary outcomes
200 sample Short Chain Fatty Acid Profile from feses sample
Time frame: 1 months
200 sample Gut Integrity profile from blood sample
Time frame: 2 months
200 sample immune response from blood sample
Time frame: 2 months
200 data hygiene practice from quenstionare data
Time frame: 2 months
200 cognitive development data from coqnitive measurement
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
- Background: PubMed 34324500Surono IS, Jalal F, Bahri S, Romulo A, Kusumo PD, Manalu E, Yusnita, Venema K. Differences in immune status and fecal SCFA between Indonesian stunted children and children with normal nutritional status. PLoS One. 2021 Jul 29;16(7):e0254300. doi: 10.1371/journal.pone.0254300. eCollection 2021.
- Results publication: PubMed 33497390Surono IS, Widiyanti D, Kusumo PD, Venema K. Gut microbiota profile of Indonesian stunted children and children with normal nutritional status. PLoS One. 2021 Jan 26;16(1):e0245399. doi: 10.1371/journal.pone.0245399. eCollection 2021.
- Derived from this study: PubMed 40716760Surono IS, Athiyyah AF, Venema K. Gut microbiota, SCFA and nutritional intake in stunted children in East Nusa Tenggara, Indonesia. Benef Microbes. 2025 Jul 24;16(6):647-658. doi: 10.1163/18762891-bja00090.
- Derived from this study: PubMed 38551926Surono IS, Popov I, Verbruggen S, Verhoeven J, Kusumo PD, Venema K. Gut microbiota differences in stunted and normal-lenght children aged 36-45 months in East Nusa Tenggara, Indonesia. PLoS One. 2024 Mar 29;19(3):e0299349. doi: 10.1371/journal.pone.0299349. eCollection 2024.
- Individual participant dataSharing planned: No. planned not to be shared
Related trials for Stunting
Not yet recruiting
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Neurodevelopment Outcome, Linear Growth
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Evaluation of REACTS-IN, an Intervention to Improve Nutrition, Hygiene, and Sexual and Reproductive Health Services
Stunting, Gender Equality
RecruitingObservational study
Impact of Diet and Nutrition on Growth and Development in Young Children
Nutrition, Growth
Active, not recruiting
Comprehensive Nutritional Support for Children in Zambia (ZamCNC) - A Pilot Investigation
Malnourished Children, Stunting of Growth
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.
Ingrid S Surono, PhD principal investigator
Bina Nusantara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stunting, run by Bina Nusantara 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 30 Aug 2022. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
200 sample Gut Microbiota Profile descript OTU by NGS (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05119218, which also lists 4 linked publications.
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 30 Aug 2022; AzTrials last refreshed its copy on 31 Oct 2026.