Gut Microbiota Stunted Children NTT

Sponsor

Bina Nusantara University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05119218

Collaborator

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

200

Enrollment

Location

3.6

Anticipated Duration (Months)

55.3

Patients Per Site Per Month

Study Details

Study Description

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,

Condition or Disease	Intervention/Treatment	Phase
Stunting	Other: No Intervention

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 [Patient Registry]

Anticipated Enrollment :

200 participants

Observational Model:

Family-Based

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Nov 2, 2021

Anticipated Primary Completion Date :

Jan 30, 2022

Anticipated Study Completion Date :

Feb 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
Stunted subject The population is all children under five aged 3-5 years in the stunting locus village. Subjects in this study were taken with a sampling quota of 100 stunting toddlers toddlers in each area.	Other: No Intervention No Intervention
Normal subject The population is all children under five aged 3-5 years in the stunting locus village. Subjects in this study were taken with a sampling quota of 100 non-stunted toddlers in each area.	Other: No Intervention No Intervention

Arm

Intervention/Treatment

Stunted subject

The population is all children under five aged 3-5 years in the stunting locus village. Subjects in this study were taken with a sampling quota of 100 stunting toddlers toddlers in each area.

Other: No Intervention

No Intervention

Normal subject

The population is all children under five aged 3-5 years in the stunting locus village. Subjects in this study were taken with a sampling quota of 100 non-stunted toddlers in each area.

Other: No Intervention

No Intervention

Outcome Measures

Primary Outcome Measures

Gut Microbiota Profile [2 months]
Profile of genus microbiota observed using Next Generation Sequencing

Secondary Outcome Measures

Short Chain Fatty Acid Profile [1 months]
microbiota metabolite profile
Gut Integrity profile [2 months]
serum lipid binding protein, serum citrulline, serum Intestinal Fatty Acid Binding Protein (IFABP), serum Fatty Acid Binding Protein (FABP), sCD14, dan sCD163.
immune response [2 months]
TNF, TGF, IL-10, dan sIgA
hygiene practice [2 months]
epidemiology data, daily hygiene practice, family data
cognitive development [2 months]
coqnitive descriptive

Eligibility Criteria

Criteria

Ages Eligible for Study:

36 Months to 45 Months

Sexes Eligible for Study:

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.