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Completed

NCT Number: NCT05119218

Gut Microbiota Stunted Children NTT

NTT Province is on the list of priority areas of high prevalence of stunting, Southwest Sumba, South Middle East, and Kupang district have a stunting prevalence of 36.2%, 34.5% and 48.1% respectively in 2020. Therefore, it is necessary to conduct a profile study. microbiota, SCFA, gastrointestinal integrity, parasites, hygiene practice, and cognition in stunting and healthy toddlers in the province of East Nusa Tenggara,

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Key information

Age range

36 month–45 month

Sex eligibility

All sexes

Study type

Observational

Primary location

University

Jakarta, DKI Jakarta, 11480, Indonesia

About this study

Stunting indicates a public health problem because it is associated with an increased risk of morbidity and mortality, decreased motor and mental function development, and reduced physical capacity. Stunting is a chronic nutritional deficiency condition that affects the growth and development, and intelligence of children. Lack of nutrients can cause intestinal microbiota dysbiosis where this will reduce the metabolism of short chain fatty acids (SCFA) which will affect the absorption of nutrients in the small intestine and cause impaired immunity, which in turn worsens stunting conditions. The composition of the gut microbiota is influenced by age, sex, geographic area and food intake. Therefore, the description of knowledge, attitudes and applications in society, especially mothers and child subjects, was also analyzed using a hygiene practice questionnaire. The aim of the study was to obtain an overview of the gut microbiota, gastrointestinal integrity, parasitic infections, hygiene practices and cognitive scores in stunting and healthy toddlers in several areas in the province of East Nusa Tenggara as a baseline study to be followed up by intervention study.

The research will be conducted for 3 (three) months in 2021/2022. The subjects involved represented 100 stunted children and 100 healthy children aged 36-45 months from each region. Determination of the sample with a sampling quota. The variables studied were the nutritional status of under five years children, characteristics of children under five (age, gender, birth weight (BBL), birth length, breast feeding history, immunization history, history of diarrhea, history of ARI (Upper Respiratory Tract Infection)), mother and family characteristics (age, education). , occupation, father's occupation, total family income), home environment and hygiene, vaccination history, gastrointestinal microbiota status, gastrointestinal integrity, parasites, hygiene practices, and cognitive scores.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Anthropometric measurements of stunting were measured based on the parameters of length/height according to age compared to the 2005 WHO anthropometric standards and the Indonesian Ministry of Health Decree No. 1995/MENKES/SK/XII/2010.

Exclusion criteria

  • criteria thats makes subject appropiate, like more than 5 years old, not live in sampling area, unhealthy

Treatment and study plan

No intervention

Other

No Intervention

Primary outcomes

  1. 200 sample Gut Microbiota Profile descript OTU by NGS

    Time frame: 2 months

    Profile of genus microbiota observed using Next Generation Sequencing

Secondary outcomes

  1. 200 sample Short Chain Fatty Acid Profile from feses sample

    Time frame: 1 months

    microbiota metabolite profile

  2. 200 sample Gut Integrity profile from blood sample

    Time frame: 2 months

    serum lipid binding protein, serum citrulline, serum Intestinal Fatty Acid Binding Protein (IFABP), serum Fatty Acid Binding Protein (FABP), sCD14, dan sCD163.

  3. 200 sample immune response from blood sample

    Time frame: 2 months

    TNF, TGF, IL-10, dan sIgA

  4. 200 data hygiene practice from quenstionare data

    Time frame: 2 months

    epidemiology data, daily hygiene practice, family data

  5. 200 cognitive development data from coqnitive measurement

    Time frame: 2 months

    coqnitive descriptive

Sponsors and collaborators

Lead sponsor

Bina Nusantara University

Other

Collaborators

  • Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia
  • Maastricht University
  • Universitas Airlangga
  • Universitas Kristen Indonesia
  • Yarsi University

Registry information

Official study title

Gut Microbiota Profile, SCFA, Gut Integrity, Parasite Infection, Hygiene Practice and Cognitive Score on Stunted Children in East Nusa Tenggara

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 15, 2021
Registry last updated
Aug 30, 2022

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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