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Clinical Trials/NCT05119218
NCT05119218CompletedNot Applicable

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

Bina Nusantara University1 site in 1 country200 target enrollmentStarted: November 2, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
200
Locations
1
Primary Endpoint
200 sample Gut Microbiota Profile descript OTU by NGS

Study Overview

Brief Summary

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,

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Family Based
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
36 Months to 45 Months (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

200 sample Gut Microbiota Profile descript OTU by NGS

Time Frame: 2 months

Profile of genus microbiota observed using Next Generation Sequencing

Secondary Outcomes

  • 200 sample immune response from blood sample(2 months)
  • 200 sample Short Chain Fatty Acid Profile from feses sample(1 months)
  • 200 sample Gut Integrity profile from blood sample(2 months)
  • 200 data hygiene practice from quenstionare data(2 months)
  • 200 cognitive development data from coqnitive measurement(2 months)

Investigators

Sponsor
Bina Nusantara University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ingrid S Surono

Principal Investigator

Bina Nusantara University

Study Sites (1)

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