Immune DeficiencyNCT04698759
Immune and Scfa Profile of Stunting Children
An observational study of Immune Deficiency and Stunting, run by Bina Nusantara University at 1 site in Indonesia.
Trial summary
1. Type and Research Design A cross-sectional study design with a quantitative approach will be conducted. Cross-sectional research design is one-time research to find a relationship between the independent variable (risk factor) and the dependent variable (effect). 2. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune Deficiency, Stunting, Fatty Acid
- How many people
- 131 participants
- Where
- 1 siteIndonesia
- Study dates
- 9 Jan 2020to 11 Nov 2020
- 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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: .A cross-sectional study design with a quantitative approach will be conducted. Cross-sectional research design is one-time research to find a relationship between the independent variable (risk factor) and the dependent variable (effect).
Who may be able to join
- Children age : 3 - 5 years old (36-60 months)
- Live in the research area
- Apparently healthy children, after examination by a physician
- Involved in a research study (informed consent signed by parent or guardian)
Who cannot join
- Children age < 36 month and > 60 month
- Live outside research area
- Unhealthy, after examination by a physician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differences in Immune Status and Fecal SCFA Between Indonesian Stunted Children and Children With Normal Nutritional Status
- Type and Research Design A cross-sectional study design with a quantitative approach will be conducted. Cross-sectional research design is one-time research to find a relationship between the independent variable (risk factor) and the dependent variable (effect).
- Time and Location of Research The research will be conducted for approximately six months in 2020 at Banten Regency (namely Tegal Ongok and Pasirkarang) and Sumedang Regency.
- Population and Research Sample The population is children between three and five years old in the village of stunting locus.
The sampling method to be used in this research was quota sampling, namely 50 stunting and 50 healthy children from each Regency.
Read the detailed description
The variables studied will be the nutritional status of children between three and five years old, the characteristics of these children (age, sex, LBW, birth length, history of immunization, history of diarrhea, history of upper respiratory tract infection, food intake), mother and family characteristics (mother's age, mother's education, mother's occupation, father's occupation), home environment (aspects of the components of the house, aspects of sanitation facilities, aspects of occupant behavior), the composition of the intestinal microbiota. Data will be obtained through measurements, interviews using a questionnaire, and direct observation using a checklist.
Stunting anthropometric measurements are measured based on parameters of length/height according to age compared to the WHO anthropometric standards 2005 and the Indonesian Minister of Health Decree No. 1995 / MENKES / SK / XII / 2010.
The nutritional status of each child included in this study will be quantified using the WHO recommended three nutritional Z-scores namely, height for age (referred to in this study as Zscore
- weight for age (referred as Z-score
- and weight for height (referred as Z-score
- .A structured questionnaire was used for face-to-face interviews with the respective child mother to collect sociodemographic information. In addition, age and anthropometric measurements (height, weight) based on the Department of Health Ministry of Indonesia The regulation will be recorded. For stunting, the thresholds for height-for-age are: 'severely stunted' (<-3 SD); 'stunted' (-3 SD to < -2 SD); 'normal' (-2 SD to +3 SD); 'tall' (> +3 SD). Furthermore, in order to obtain an overall measure of the nutritional status of these children, the children will be classified into weight-for-height categories: 'severely wasted' (<-3 SD); 'wasted' (-3 SD to < -2 SD); 'normal' (-2 SD to +1 SD); 'possible risk of overweight' (+1 SD to +2 SD); 'overweight' (> +2 SD to +3 SD); 'obese' (> +3 SD)
- Conditions
- Immune Deficiency, Stunting, Fatty Acid
- Being tested
- No Intervention
- Keywords
- immune status, stunting, Normal Nutritional Status, Indonesian Children, Gut Microbiota, SCFA
- Medical subject headings
- Immunologic Deficiency Syndromes, 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 | Children with stunted status condition based on Z score criteria Receives: Other: No Intervention | |
| Normal subject | Children with normal status condition based on Z score criteria Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
TGF beta
Unit : pg/mL from serum
Measured: 1 week analysis
sIgA
Unit : ul/ml from feses extract
Measured: 1 week analysis
IL -10
unit pg/ml from serum
Measured: 1 week analysis
TNF alfa
unit pg/mL from serum
Measured: 1 week analysis
LBP
Unit ul/ml from serum
Measured: 1 week analysis
Secondary outcomes (1)
Short Chain Fatty Acid
Acetate, Propionate, Butyrate, Isobutyric, Isopropionic , unit mM
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start9 Jan 2020
- Primary completion11 Oct 2020
- Study completion11 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Immune DeficiencyStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bina Nusantara University
- Sponsor type
- University, hospital or other
- Collaborators
- Yayasan Rumah Sakit Islam (YARSI) University, Universitas Kristen Indonesia, Maastricht University
- 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
- NCT04698759
- Sponsor's protocol ID
- No.026/VR.RTT/IV/202
- Status last verified
- Jan 2021
- First submitted
- 5 Jan 2021
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grantham-McGregor S, Cheung YB, Cueto S, Glewwe P, Richter L, Strupp B; International Child Development Steering Group. Developmental potential in the first 5 years for children in developing countries. Lancet. 2007 Jan 6;369(9555):60-70. doi: 10.1016/S0140-6736(07)60032-4.
PubMed 17208643Titaley CR, Ariawan I, Hapsari D, Muasyaroh A, Dibley MJ. Determinants of the Stunting of Children Under Two Years Old in Indonesia: A Multilevel Analysis of the 2013 Indonesia Basic Health Survey. Nutrients. 2019 May 18;11(5):1106. doi: 10.3390/nu11051106.
PubMed 31109058Surono 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 34324500
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Immune Status and Fecal SCFA Between Indonesian Stunted Children and Children With Normal Nutritional Status
- ClinicalTrials.gov ID
- NCT04698759
- Acronym / sponsor ID
- No.026/VR.RTT/IV/202
- Conditions
- Immune Deficiency, Stunting, Fatty Acid
- Keywords
- immune status, stunting, Normal Nutritional Status, Indonesian Children, Gut Microbiota, SCFA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Bina Nusantara UniversityUniversity, hospital or other
- Collaborators
- Yayasan Rumah Sakit Islam (YARSI) University, Universitas Kristen Indonesia, Maastricht University
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 11 Oct 2020 (actual)
- Study completion
- 11 Nov 2020 (actual)
- First posted
- 7 Jan 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.
- Type and Research Design A cross-sectional study design with a quantitative approach will be conducted. Cross-sectional research design is one-time research to find a relationship between the independent variable (risk factor) and the dependent variable (effect).
- Time and Location of Research The research will be conducted for approximately six months in 2020 at Banten Regency (namely Tegal Ongok and Pasirkarang) and Sumedang Regency.
- Population and Research Sample The population is children between three and five years old in the village of stunting locus.
The sampling method to be used in this research was quota sampling, namely 50 stunting and 50 healthy children from each Regency.
Detailed description
The variables studied will be the nutritional status of children between three and five years old, the characteristics of these children (age, sex, LBW, birth length, history of immunization, history of diarrhea, history of upper respiratory tract infection, food intake), mother and family characteristics (mother's age, mother's education, mother's occupation, father's occupation), home environment (aspects of the components of the house, aspects of sanitation facilities, aspects of occupant behavior), the composition of the intestinal microbiota. Data will be obtained through measurements, interviews using a questionnaire, and direct observation using a checklist.
Stunting anthropometric measurements are measured based on parameters of length/height according to age compared to the WHO anthropometric standards 2005 and the Indonesian Minister of Health Decree No. 1995 / MENKES / SK / XII / 2010.
The nutritional status of each child included in this study will be quantified using the WHO recommended three nutritional Z-scores namely, height for age (referred to in this study as Zscore
- weight for age (referred as Z-score
- and weight for height (referred as Z-score
- .A structured questionnaire was used for face-to-face interviews with the respective child mother to collect sociodemographic information. In addition, age and anthropometric measurements (height, weight) based on the Department of Health Ministry of Indonesia The regulation will be recorded. For stunting, the thresholds for height-for-age are: 'severely stunted' (<-3 SD); 'stunted' (-3 SD to < -2 SD); 'normal' (-2 SD to +3 SD); 'tall' (> +3 SD). Furthermore, in order to obtain an overall measure of the nutritional status of these children, the children will be classified into weight-for-height categories: 'severely wasted' (<-3 SD); 'wasted' (-3 SD to < -2 SD); 'normal' (-2 SD to +1 SD); 'possible risk of overweight' (+1 SD to +2 SD); 'overweight' (> +2 SD to +3 SD); 'obese' (> +3 SD)
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stunted subject | – | Other: No InterventionChildren with stunted status condition based on Z score criteria |
| Normal subject | – | Other: No InterventionChildren with normal status condition based on Z score criteria |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- .A cross-sectional study design with a quantitative approach will be conducted. Cross-sectional research design is one-time research to find a relationship between the independent variable (risk factor) and the dependent variable (effect).
Key inclusion criteria (4 listed)
- Children age : 3 - 5 years old (36-60 months)
- Live in the research area
- Apparently healthy children, after examination by a physician
- Involved in a research study (informed consent signed by parent or guardian)
Key exclusion criteria (3 listed)
- Children age < 36 month and > 60 month
- Live outside research area
- Unhealthy, after examination by a physician
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
TGF beta
Time frame: 1 week analysis
Unit : pg/mL from serum
sIgA
Time frame: 1 week analysis
Unit : ul/ml from feses extract
IL -10
Time frame: 1 week analysis
unit pg/ml from serum
TNF alfa
Time frame: 1 week analysis
unit pg/mL from serum
LBP
Time frame: 1 week analysis
Unit ul/ml from serum
1 secondary outcome
Short Chain Fatty Acid
Time frame: 1 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 15 Jan 2021.
- Background: PubMed 17208643Grantham-McGregor S, Cheung YB, Cueto S, Glewwe P, Richter L, Strupp B; International Child Development Steering Group. Developmental potential in the first 5 years for children in developing countries. Lancet. 2007 Jan 6;369(9555):60-70. doi: 10.1016/S0140-6736(07)60032-4.
- Results publication: PubMed 31109058Titaley CR, Ariawan I, Hapsari D, Muasyaroh A, Dibley MJ. Determinants of the Stunting of Children Under Two Years Old in Indonesia: A Multilevel Analysis of the 2013 Indonesia Basic Health Survey. Nutrients. 2019 May 18;11(5):1106. doi: 10.3390/nu11051106.
- Derived from this study: 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.
- Individual participant dataSharing planned: No
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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 Immune Deficiency and 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 4 inclusion and 3 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 15 Jan 2021. 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?
TGF beta (time frame: 1 week analysis). The study lists 5 primary outcomes in all. 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 NCT04698759, which also lists 3 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 15 Jan 2021.