- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05119218
Gut Microbiota Stunted Children NTT
Gut Microbiota Profile, SCFA, Gut Integrity, Parasite Infection, Hygiene Practice and Cognitive Score on Stunted Children in East Nusa Tenggara
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
DKI Jakarta
-
Jakarta, DKI Jakarta, Indonesia, 11480
- University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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.
|
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.
|
No Intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
200 sample Gut Microbiota Profile descript OTU by NGS
Time Frame: 2 months
|
Profile of genus microbiota observed using Next Generation Sequencing
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
200 sample Short Chain Fatty Acid Profile from feses sample
Time Frame: 1 months
|
microbiota metabolite profile
|
1 months
|
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.
|
2 months
|
200 sample immune response from blood sample
Time Frame: 2 months
|
TNF, TGF, IL-10, dan sIgA
|
2 months
|
200 data hygiene practice from quenstionare data
Time Frame: 2 months
|
epidemiology data, daily hygiene practice, family data
|
2 months
|
200 cognitive development data from coqnitive measurement
Time Frame: 2 months
|
coqnitive descriptive
|
2 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ingrid S Surono, PhD, Bina Nusantara University
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 332/KEP-UY/BIA/X/2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stunting
-
International Centre for Diarrhoeal Disease Research...University of WashingtonCompletedNutritional StuntingBangladesh
-
Washington University School of MedicineKamuzu University of Health Sciences; Project Peanut Butter, MalawiCompletedNutritional StuntingMalawi
-
Indonesia UniversityWyeth nutrition indonesiaCompletedGrowth; Stunting, NutritionalIndonesia
-
Danone Asia Pacific Holdings Pte, Ltd.KK Women's and Children's HospitalCompletedGrowth; Stunting, NutritionalSingapore
-
University of South CarolinaHelen Keller InternationalCompleted
-
International Centre for Diarrhoeal Disease Research...Department for International Development, United Kingdom; University of Sydney and other collaboratorsCompleted
-
Swiss Federal Institute of TechnologyBRAC University; HarvestPlusCompletedZinc Deficiency | Growth; Stunting, NutritionalSwitzerland, Bangladesh
-
University of CopenhagenUniversity of Aarhus; Arla FoodsCompletedGrowth Acceleration | Growth; Stunting, NutritionalDenmark
-
Andalas UniversityIndonesia UniversityCompletedGastrointestinal Microbiome | Growth; Stunting, Nutritional | Immunoglobulin AIndonesia
-
University of WashingtonFrankel Family Foundation; Stewardship FoundationActive, not recruitingBreastfeeding, Exclusive | Immunization; Infection | Growth; Stunting, NutritionalEthiopia
Clinical Trials on No Intervention
-
Wave NeuroscienceCompletedAutistic DisorderUnited States
-
University of Alabama at BirminghamCompletedInflammatory Bowel Diseases | Colorectal Cancer | Diverticular Diseases | Social BehaviorUnited States
-
Janssen Research & Development, LLCCompletedLupus Erythematosus, Systemic | Lupus Erythematosus, Cutaneous | Lupus Erythematosus, DiscoidUnited States, Poland
-
Hospital Universitario La Paz3MVX CCB and Agaplesion Markus Krankenhaus, Frankfurt a.M., Germany.; Department...RecruitingEmbolism | Atrial Fibrillation | Arrhythmia | Stroke, Acute | Stroke Sequelae | AblationSpain
-
Southern California College of Optometry at Marshall...Ohio State University; University of Houston; Alcon Research; University of Waterloo and other collaboratorsCompletedContact Lens Complication | Contact Lens Acute Red Eye | Contact Lens Related Corneal Infiltrate (Disorder) | Contact Lens-Induced Corneal Fluorescein StainingUnited States, Canada
-
University of Dublin, Trinity CollegeCompleted
-
Hôpital Necker-Enfants MaladesUnknown
-
China Medical University HospitalUnknownIntention to Stay, Turnover Behavior
-
University of PittsburghCompletedChronic Low Back PainUnited States