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OpenTrials
Completed

NCT Number: NCT04698759

Immune and Scfa Profile of Stunting Children

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.

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Key information

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University

Jakarta, Indonesia

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

no Intervention

Primary outcomes

  1. TGF beta

    Time frame: 1 week analysis

    Unit : pg/mL from serum

  2. sIgA

    Time frame: 1 week analysis

    Unit : ul/ml from feses extract

  3. IL -10

    Time frame: 1 week analysis

    unit pg/ml from serum

  4. TNF alfa

    Time frame: 1 week analysis

    unit pg/mL from serum

  5. LBP

    Time frame: 1 week analysis

    Unit ul/ml from serum

Secondary outcomes

  1. Short Chain Fatty Acid

    Time frame: 1 months

    Acetate, Propionate, Butyrate, Isobutyric, Isopropionic , unit mM

Other outcomes

  1. Microbiota profile

    Time frame: 2 months

    relative abundance microbiota profile

Sponsors and collaborators

Lead sponsor

Bina Nusantara University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 7, 2021
Registry last updated
Jan 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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