Immune and Scfa Profile of Stunting Children

Overview

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.

Full Title of Study: “Differences in Immune Status and Fecal SCFA Between Indonesian Stunted Children and Children With Normal Nutritional Status”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: October 11, 2020

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)

Interventions

  • Other: No Intervention
    • no Intervention

Arms, Groups and Cohorts

  • Stunted subject
    • Children with stunted status condition based on Z score criteria
  • Normal subject
    • Children with normal status condition based on Z score criteria

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • Short Chain Fatty Acid
    • Time Frame: 1 months
    • Acetate, Propionate, Butyrate, Isobutyric, Isopropionic , unit mM

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 3 Years

Maximum Age: 5 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Bina Nusantara University
  • Collaborator
    • Yayasan Rumah Sakit Islam (YARSI) University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ingrid S Surono, Principal Investigator – Bina Nusantara University
  • Overall Official(s)
    • Ingrid S Surono, PhD, Principal Investigator, Bina Nusantara University

References

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.

Citations Reporting on Results

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.

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