Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04515264 |
| Other study ID # |
HMOs Indonesia 1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2021 |
| Est. completion date |
April 22, 2022 |
Study information
| Verified date |
August 2022 |
| Source |
Indonesia University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The breastfeeding rates globally in Indonesia generally remain low with only 40% or less
infants aged 6 months are exclusively breastfed. Available national data in 2018 showed the
proportion of wasted in children under 5 years old was 6.7%, while 3.5% children were
severely wasted. This data showed improvement compared data in 2007 and 2013. While
proportion children under 2 years old with stunted and severly stunted was 29.9%. As the
third most abundant group of compounds in human milk, after lactose (70 g/L) and lipids (40
g/L), human milk oligosaccharides (HMOs) never been study in Indonesia. HMOs amount and
diversity influenced by non modifiable and modifiable factors. The maternal phenotypes, the
α-1-2-fucosyltransferase (FUT-2) gene and the α-1-3-4-fucosyltransferase (FUT-3) gene divided
the mother into secretor (Se+) and non secretor (Se-) and Le+ or Le-). Studies showed the
breastfed infants of non secretor mothers secrete lower HMOs than secretor mothers. By many
functions in HMOs such as prebiotic, anti infection, modulate immunity, it is thought that
HMOs can influence infant growth. The hypothesis of this study is to show the associations
between maternal factors (secretor gene status/FUT-2 gene, lewis gene status/FUT-3 gene,
gestational age and gestational weight gain) with HMOs profiles and growth indicators of
infants aged 0-4 months.
Description:
This study is a prospective longitudinal study to analyze the association between HMOs
profiles and growth indicators of infants age 0-4 months. In this longitudinal study, the
human milk, anthropometry assessment and questionnaires will be collect in the 0, 2, 4 month
of age. Gestational age and birth weight will be obtain from the medical status upon
enrollment.
The study will be conduct in Government & Private Hospital in Jakarta between Juli - December
2020. Based on sample size calculation, the total minimal samples are 120 samples. Subjects
recruitment will be based on nonprobabilistic consecutive sampling to post partum inpatient
mothers in Government & Private Hospital in Jakarta between Juli - December 2020.
Study forms consist of study information, informed consent, screening form, baseline data,
follow up form and laboratory result form. The tools requirements are among others Seca 728
electronic infant scale, Anthropometry Plus (AnthroPlus) Software, World Health Organization
(WHO) growth velocity chart, Questionnaires, Thermometer, 15 mL polypropylene tube,
Disposable gloves and vacuum bag with dry ice. The specimens obtain for this study are 15 mL
venous blood for genotyping and 10 mL breast milk (0, 2, 4 month).
After obtaining clearance from Ethical Committee of the Faculty of Medicine University of
Indonesia, the post partum mothers will be presented with Form A (study information form).
Patients will be informed about the aim, benefits and procedures of the study. If patients
agree, she will have to sign the informed consent (Form B).
Study phases consists of
1. screening : description of the aims, benefits and procedures of the study, filling the
informed consent, screening based on inclusion and exclusion criteria.
2. Data collection :
- Interview. Interview will be done to fill information in Form C and D.
- Subjects selected during the screening visit will follow a 4 month study. Primary
and secondary outcomes will be measured at 0, 2, 4 months (visit 1-2-3).
3. Data analysis :
1. All data will be edited, coded and entry to the computer. The Statistical Package
for the Social Sciences (SPSS) for windows version 20.0 will be use for data
analyzing.
2. Univariate analysis will be conduct to know the distribution of each variables.
Test of normality of the data will be perform with Kolmogorov-Smirnov test at the
significance level p>0.05 as normally distributed data. The continuous data will be
present as mean ± standard deviation and for categorical data in n (%) for normally
distributed data and geometric mean ± standard deviation forn non-normally
distributed data.
3. For bivariate analysis, Pearson correlation test will be performed if the data is
normally distributed or Spearman Rank test if the data is non-normally distributed.
Reference for rho value show in Table 3.3.
4. Multivariate analysis will be conduct by linear regression model.
