Clinical trial NCT05119218: Gut Microbiota Stunted Children NTT
Official title: Gut Microbiota Profile, SCFA, Gut Integrity, Parasite Infection, Hygiene Practice and Cognitive Score on Stunted Children in East Nusa Tenggara
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stunting
Keywords: stunting
Gut microbiota
toddler
SCFA
Parasite
Hygiene Practice
Lead sponsor: Bina Nusantara University
Sponsor class: OTHER
Collaborators: name: Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia
name: Maastricht University
name: Universitas Airlangga
name: Yarsi University
name: Universitas Kristen Indonesia
First posted: 2021-11-15
Enrollment: 200
Sex: ALL
Minimum age (years): 36
Maximum age (years): 45
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: This observational study used a cross sectional design with a quantitative approach. The cross-sectional research design is a research conducted at one time and one time to find the relationship between the independent variable (risk factor) and the dependent variable (effect) as baseline data

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.

Eligibility criteria: 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

Primary outcomes:
measure: 200 sample Gut Microbiota Profile descript OTU by NGS
timeFrame: 2 months
Secondary outcomes:
measure: 200 sample Short Chain Fatty Acid Profile from feses sample
timeFrame: 1 months
measure: 200 sample Gut Integrity profile from blood sample
timeFrame: 2 months
measure: 200 sample immune response from blood sample
timeFrame: 2 months
measure: 200 data hygiene practice from quenstionare data
timeFrame: 2 months
measure: 200 cognitive development data from coqnitive measurement
timeFrame: 2 months
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: University
state: DKI Jakarta
Study officials:
affiliation: Bina Nusantara University
name: Ingrid S Surono, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Surono IS, Jalal F, Bahri S, Romulo A, Kusumo PD, Manalu E, Yusnita, Venema K. Differences in immune status and fecal SCFA between Indonesian stunted children and children with normal nutritional status. PLoS One. 2021 Jul 29;16(7):e0254300. doi: 10.1371/journal.pone.0254300. eCollection 2021.
citation: Surono IS, Widiyanti D, Kusumo PD, Venema K. Gut microbiota profile of Indonesian stunted children and children with normal nutritional status. PLoS One. 2021 Jan 26;16(1):e0245399. doi: 10.1371/journal.pone.0245399. eCollection 2021.