Immune and Scfa Profile of Stunting Children

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

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.

Study Overview

• Status: Completed
• Conditions: Stunting; Immune Deficiency; Fatty Acid
• Intervention / Treatment: Other: No Intervention

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)

• Study Type: Observational
• Enrollment (Actual): 131

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta, Indonesia
    • University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 5 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Stunted subject; Children with stunted status condition based on Z score criteria	Other: No Intervention; no Intervention
Normal subject; Children with normal status condition based on Z score criteria	Other: No Intervention; no Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TGF beta	Unit : pg/mL from serum	1 week analysis
sIgA	Unit : ul/ml from feses extract	1 week analysis
IL -10	unit pg/ml from serum	1 week analysis
TNF alfa	unit pg/mL from serum	1 week analysis
LBP	Unit ul/ml from serum	1 week analysis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Chain Fatty Acid	Acetate, Propionate, Butyrate, Isobutyric, Isopropionic , unit mM	1 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiota profile	relative abundance microbiota profile	2 months

Collaborators and Investigators

• Sponsor: Bina Nusantara University
• Collaborators: Maastricht University; Yayasan Rumah Sakit Islam (YARSI) University; Universitas Kristen Indonesia
• Investigators: Principal Investigator: Ingrid S Surono, PhD, Bina Nusantara University

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2020
• Primary Completion (Actual): October 11, 2020
• Study Completion (Actual): November 11, 2020

Study Registration Dates

• First Submitted: January 5, 2021
• First Submitted That Met QC Criteria: January 5, 2021
• First Posted (Actual): January 7, 2021

Study Record Updates

• Last Update Posted (Actual): January 15, 2021
• Last Update Submitted That Met QC Criteria: January 13, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Gut Microbiota; stunting; immune status; SCFA; Normal Nutritional Status; Indonesian Children
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Immunologic Deficiency Syndromes; Growth Disorders
• Other Study ID Numbers: No.026/VR.RTT/IV/202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No