Gut Microbiota Stunted Children NTT

Stunting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05119218
• Other study ID #: 332/KEP-UY/BIA/X/2021
• Status: Completed
• Start date: November 2, 2021
• Est. completion date: February 20, 2022

Study information

• Verified date: August 2022
• Source: Bina Nusantara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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,

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 20, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 36 Months to 45 Months

Eligibility

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

Related Conditions & MeSH terms

• Growth Disorders
• Stunting

Intervention

Other:
• No Intervention
No Intervention

Locations

Country	Name	City	State
Indonesia	University	Jakarta	DKI Jakarta

Sponsors (6)

Lead Sponsor	Collaborator
Bina Nusantara University	Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia, Maastricht University, Universitas Airlangga, Universitas Kristen Indonesia, Yarsi University

Country where clinical trial is conducted

Indonesia, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	200 sample Gut Microbiota Profile descript OTU by NGS	Profile of genus microbiota observed using Next Generation Sequencing	2 months
Secondary	200 sample Short Chain Fatty Acid Profile from feses sample	microbiota metabolite profile	1 months
Secondary	200 sample Gut Integrity profile from blood sample	serum lipid binding protein, serum citrulline, serum Intestinal Fatty Acid Binding Protein (IFABP), serum Fatty Acid Binding Protein (FABP), sCD14, dan sCD163.	2 months
Secondary	200 sample immune response from blood sample	TNF, TGF, IL-10, dan sIgA	2 months
Secondary	200 data hygiene practice from quenstionare data	epidemiology data, daily hygiene practice, family data	2 months
Secondary	200 cognitive development data from coqnitive measurement	coqnitive descriptive	2 months