Immune and Scfa Profile of Stunting Children

Sponsor
Bina Nusantara University (Other)
Overall Status
Completed
CT.gov ID
NCT04698759
Collaborator
Yayasan Rumah Sakit Islam (YARSI) University (Other), Universitas Kristen Indonesia (Other), Maastricht University (Other)
131
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10.1
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
131 participants
Observational Model:
Ecologic or Community
Time Perspective:
Cross-Sectional
Official Title:
Differences in Immune Status and Fecal SCFA Between Indonesian Stunted Children and Children With Normal Nutritional Status
Actual Study Start Date :
Jan 9, 2020
Actual Primary Completion Date :
Oct 11, 2020
Actual Study Completion Date :
Nov 11, 2020

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. TGF beta [1 week analysis]

    Unit : pg/mL from serum

  2. sIgA [1 week analysis]

    Unit : ul/ml from feses extract

  3. IL -10 [1 week analysis]

    unit pg/ml from serum

  4. TNF alfa [1 week analysis]

    unit pg/mL from serum

  5. LBP [1 week analysis]

    Unit ul/ml from serum

Secondary Outcome Measures

  1. Short Chain Fatty Acid [1 months]

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

Other Outcome Measures

  1. Microbiota profile [2 months]

    relative abundance microbiota profile

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 5 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Jakarta Indonesia

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Ingrid S Surono, PhD, Bina Nusantara University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ingrid S Surono, Principal Investigator, Bina Nusantara University
ClinicalTrials.gov Identifier:
NCT04698759
Other Study ID Numbers:
  • No.026/VR.RTT/IV/202
First Posted:
Jan 7, 2021
Last Update Posted:
Jan 15, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ingrid S Surono, Principal Investigator, Bina Nusantara University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 15, 2021