Clinical trial NCT04698759: Immune and Scfa Profile of Stunting Children
Official title: Differences in Immune Status and Fecal SCFA Between Indonesian Stunted Children and Children With Normal Nutritional Status
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immune Deficiency
Stunting
Fatty Acid
Keywords: immune status
stunting
Normal Nutritional Status
Indonesian Children
Gut Microbiota
SCFA
Lead sponsor: Bina Nusantara University
Sponsor class: OTHER
Collaborators: name: Yayasan Rumah Sakit Islam (YARSI) University
name: Universitas Kristen Indonesia
name: Maastricht University
First posted: 2021-01-07
Enrollment: 131
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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).

Brief 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. 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.
3. 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

1. weight for age (referred as Z-score
2. and weight for height (referred as Z-score
3. .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)

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* Children age \< 36 month and \> 60 month
* Live outside research area
* Unhealthy, after examination by a physician

Primary outcomes:
measure: TGF beta
timeFrame: 1 week analysis
measure: sIgA
timeFrame: 1 week analysis
measure: IL -10
timeFrame: 1 week analysis
measure: TNF alfa
timeFrame: 1 week analysis
measure: LBP
timeFrame: 1 week analysis
Secondary outcomes:
measure: Short Chain Fatty Acid
timeFrame: 1 months
Other outcomes:
measure: Microbiota profile
timeFrame: 2 months
Locations:
city: Jakarta
country: Indonesia
facility: University
Study officials:
affiliation: Bina Nusantara University
name: Ingrid S Surono, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Titaley 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.
citation: 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.