NCT05119218

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,

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

November 2, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 15, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2022

Completed
Last Updated

August 30, 2022

Status Verified

August 1, 2022

Enrollment Period

3 months

First QC Date

November 2, 2021

Last Update Submit

August 25, 2022

Conditions

Stunting

Keywords

stuntingGut microbiotatoddlerSCFAParasiteHygiene Practice

Outcome Measures

Primary Outcomes (1)

  • 200 sample Gut Microbiota Profile descript OTU by NGS

    Profile of genus microbiota observed using Next Generation Sequencing

    2 months

Secondary Outcomes (5)

  • 200 sample Short Chain Fatty Acid Profile from feses sample

    1 months

  • 200 sample Gut Integrity profile from blood sample

    2 months

  • 200 sample immune response from blood sample

    2 months

  • 200 data hygiene practice from quenstionare data

    2 months

  • 200 cognitive development data from coqnitive measurement

    2 months

Study Arms (2)

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

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

Interventions

No InterventionOTHER

No Intervention

Normal subjectStunted subject

Eligibility Criteria

Age36 Months - 45 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability 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

You may qualify if:

  • 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.

You may not qualify if:

  • criteria thats makes subject appropiate, like more than 5 years old, not live in sampling area, unhealthy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University

Jakarta, DKI Jakarta, 11480, Indonesia

Location

Related Publications (4)

  • 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.

    PMID: 34324500BACKGROUND

  • 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.

    PMID: 33497390RESULT

  • Surono IS, Athiyyah AF, Venema K. Gut microbiota, SCFA and nutritional intake in stunted children in East Nusa Tenggara, Indonesia. Benef Microbes. 2025 Jul 24;16(6):647-658. doi: 10.1163/18762891-bja00090.

    PMID: 40716760DERIVED

  • Surono IS, Popov I, Verbruggen S, Verhoeven J, Kusumo PD, Venema K. Gut microbiota differences in stunted and normal-lenght children aged 36-45 months in East Nusa Tenggara, Indonesia. PLoS One. 2024 Mar 29;19(3):e0299349. doi: 10.1371/journal.pone.0299349. eCollection 2024.

    PMID: 38551926DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

stool and blood sampling

MeSH Terms

Conditions

Growth Disorders

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ingrid S Surono, PhD

    Bina Nusantara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
CROSS SECTIONAL
Target Duration
3 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 2, 2021

First Posted

November 15, 2021

Study Start

November 2, 2021

Primary Completion

January 30, 2022

Study Completion

February 20, 2022

Last Updated

August 30, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

planned not to be shared

Locations

ID(1)