Immune and Scfa Profile of Stunting Children

Differences in Immune Status and Fecal SCFA Between Indonesian Stunted Children and Children With Normal Nutritional Status

Sponsors

Lead Sponsor: Bina Nusantara University

Collaborator: Yayasan Rumah Sakit Islam (YARSI) University
Universitas Kristen Indonesia
Maastricht University

Source Bina Nusantara University
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)

Overall Status Completed
Start Date January 9, 2020
Completion Date November 11, 2020
Primary Completion Date October 11, 2020
Study Type Observational
Primary Outcome
Measure Time Frame
TGF beta 1 week analysis
sIgA 1 week analysis
IL -10 1 week analysis
TNF alfa 1 week analysis
LBP 1 week analysis
Secondary Outcome
Measure Time Frame
Short Chain Fatty Acid 1 months
Enrollment 131
Condition
Intervention

Intervention Type: Other

Intervention Name: No Intervention

Description: no Intervention

Eligibility

Sampling Method: Non-Probability Sample

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

Gender: All

Minimum Age: 3 Years

Maximum Age: 5 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Ingrid S Surono, PhD Principal Investigator Bina Nusantara University
Location
Facility: University
Location Countries

Indonesia

Verification Date

January 2021

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Bina Nusantara University

Investigator Full Name: Ingrid S Surono

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Stunted subject

Description: Children with stunted status condition based on Z score criteria

Label: Normal subject

Description: Children with normal status condition based on Z score criteria

Patient Data No
Study Design Info

Observational Model: Ecologic or Community

Time Perspective: Cross-Sectional

Source: ClinicalTrials.gov