Immune and Scfa Profile of Stunting Children | NCT04698759

Studies
Immune and Scfa Profile of Stunting Children

NCT04698759

Sponsor

Bina Nusantara University

Status

Completed

Last Update Posted

Jan 15, 2021Actual

Enrollment

131Actual

Phase

Not provided

Conditions

Immune Deficiency
Stunting
Fatty Acid

Interventions

No Intervention

Countries

Indonesia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 9, 2020Actual

Primary Completion Date

Oct 11, 2020Actual

Completion Date

Nov 11, 2020Actual

First Submitted Date

Jan 5, 2021

First Submission Date that Met QC Criteria

Jan 5, 2021

First Posted Date

Jan 7, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 13, 2021

Last Update Posted Date

Jan 15, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ingrid S Surono, Principal Investigator, Bina Nusantara UniversityPrincipal Investigator

Lead Sponsor

Bina Nusantara UniversityOTHER

Collaborators

Name	Class
Yayasan Rumah Sakit Islam (YARSI) University	UNKNOWN
Universitas Kristen Indonesia	OTHER
Maastricht University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Type and Research Design A cross-sectional study design with a quantitative approach will be conducted. Cross-sectional research design is one-time research to find a relationship between the independent variable (risk factor) and the dependent variable (effect).
Time and Location of Research The research will be conducted for approximately six months in 2020 at Banten Regency (namely Tegal Ongok and Pasirkarang) and Sumedang Regency.
Population and Research Sample The population is children between three and five years old in the village of stunting locus.

The sampling method to be used in this research was quota sampling, namely 50 stunting and 50 healthy children from each Regency.

Detailed Description

The variables studied will be the nutritional status of children between three and five years old, the characteristics of these children (age, sex, LBW, birth length, history of immunization, history of diarrhea, history of upper respiratory tract infection, food intake), mother and family characteristics (mother's age, mother's education, mother's occupation, father's occupation), home environment (aspects of the components of the house, aspects of sanitation facilities, aspects of occupant behavior), the composition of the intestinal microbiota. Data will be obtained through measurements, interviews using a questionnaire, and direct observation using a checklist.

Stunting anthropometric measurements are measured based on parameters of length/height according to age compared to the WHO anthropometric standards 2005 and the Indonesian Minister of Health Decree No. 1995 / MENKES / SK / XII / 2010.

The nutritional status of each child included in this study will be quantified using the WHO recommended three nutritional Z-scores namely, height for age (referred to in this study as Zscore

weight for age (referred as Z-score
and weight for height (referred as Z-score
.A structured questionnaire was used for face-to-face interviews with the respective child mother to collect sociodemographic information. In addition, age and anthropometric measurements (height, weight) based on the Department of Health Ministry of Indonesia The regulation will be recorded. For stunting, the thresholds for height-for-age are: 'severely stunted' (<-3 SD); 'stunted' (-3 SD to < -2 SD); 'normal' (-2 SD to +3 SD); 'tall' (> +3 SD). Furthermore, in order to obtain an overall measure of the nutritional status of these children, the children will be classified into weight-for-height categories: 'severely wasted' (<-3 SD); 'wasted' (-3 SD to < -2 SD); 'normal' (-2 SD to +1 SD); 'possible risk of overweight' (+1 SD to +2 SD); 'overweight' (> +2 SD to +3 SD); 'obese' (> +3 SD)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

131Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stunted subject		Children with stunted status condition based on Z score criteria	Other: No Intervention
Normal subject		Children with normal status condition based on Z score criteria	Other: No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No Intervention	Other	no Intervention	Normal subject Stunted subject

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
TGF beta	Unit : pg/mL from serum	1 week analysis
sIgA	Unit : ul/ml from feses extract	1 week analysis
IL -10	unit pg/ml from serum	1 week analysis
TNF alfa	unit pg/mL from serum	1 week analysis
LBP	Unit ul/ml from serum	1 week analysis

Secondary Outcomes

Measure	Description	Time Frame
Short Chain Fatty Acid	Acetate, Propionate, Butyrate, Isobutyric, Isopropionic , unit mM	1 months

Other Outcomes

Measure	Description	Time Frame
Microbiota profile	relative abundance microbiota profile	2 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children age : 3 - 5 years old (36-60 months)
Live in the research area
Apparently healthy children, after examination by a physician
Involved in a research study (informed consent signed by parent or guardian)

Exclusion Criteria:

Children age < 36 month and > 60 month
Live outside research area
Unhealthy, after examination by a physician

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

5 Years

Standard Ages

Child

Study Population

.A cross-sectional study design with a quantitative approach will be conducted. Cross-sectional research design is one-time research to find a relationship between the independent variable (risk factor) and the dependent variable (effect).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ingrid S Surono, PhD	Bina Nusantara University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University		Jakarta			Indonesia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17208643	Background	Grantham-McGregor S, Cheung YB, Cueto S, Glewwe P, Richter L, Strupp B; International Child Development Steering Group. Developmental potential in the first 5 years for children in developing countries. Lancet. 2007 Jan 6;369(9555):60-70. doi: 10.1016/S0140-6736(07)60032-4.
31109058	Result	Titaley CR, Ariawan I, Hapsari D, Muasyaroh A, Dibley MJ. Determinants of the Stunting of Children Under Two Years Old in Indonesia: A Multilevel Analysis of the 2013 Indonesia Basic Health Survey. Nutrients. 2019 May 18;11(5):1106. doi: 10.3390/nu11051106.

ID	Term
D007153	Immunologic Deficiency Syndromes
D006130	Growth Disorders

ID	Term
D007154	Immune System Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms