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| ID | Type | Description | Link |
|---|---|---|---|
| NKB3239/UN2.RST/HKP.05.00/2020 | Other Grant/Funding Number | PUTI Grant by Universitas Indonesia |
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| Name | Class |
|---|---|
| Indonesia University | OTHER |
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The aim of our study is to assess the effect of giving dadiah as a supplement to pregnant women on improving the growth and digestive health of children.
The study was carried out on pregnant women in four Public Health Center (PHC) areas in Padang Panjang, West Sumatra, Indonesia. They were screened for inclusion and exclusion criteria. Once eligibility was confirmed, pregnant women were randomly allocated to intervention or control groups. The details of the study protocol were explained, and voluntary written consent was obtained.
General information about the mother was collected and a general physical examination was assessed. The intervention started at about 10-20 weeks of gestation and continued until just before the time of delivery. Subjects took the study supplements concurrently with the government's dietary supplementation program. In each home visit, the remaining supplements from the previous visit were counted and documented in the pudding checklist form. Details of symptoms or illnesses during consumption of dadiah pudding will be reported either by participants directly contacting field officers, study staff, or during weekly visits and will be recorded and documented in the case report form. In the third trimester, subjects received healthy food, breastfeeding practices, and child development education to support mothers in maintaining their nutritional status, preparing exclusive breastfeeding, and optimizing child development.
Healthy babies born to mothers will be the focus of this study and followed up until the age of three months to assess their growth. The information includes the baby's health history after birth, anthropometric measurements, nutritional intake, and breastfeeding practices which are measured repeatedly in the first, second, and third months. The collection of breast milk and baby feces is carried out in the first week and third month after the baby is born.
The sample size was calculated taking into account all outcome variables including the proportion of gut microbiota, levels of IgA secretion in breast milk and infant feces, and child growth, with the independent variable being maternal supplementation during pregnancy.
Data quality assurance is carried out through training starting from the period of data collection and supervision during and after data collection, including the data analysis process. This included training for enumerators, subjects and using a validated questionnaire for a group of subjects representing similar characteristics for this study. Data input and cleaning process will use excel and SPSS while for food intake data using NutriSurvey 2007. Data entry will be carried out by data collection officers after data collection. The data cleaning process includes removing outliers and regrouping multiple results that have similar meanings. The data will be interpreted as mean ± standard deviation if the data is normally distributed and the median (min-max) if the data is not normally distributed. Statistical analysis using SPSS 20 and data will be analyzed using univariate and bivariate analysis. Univariate analysis is used to describe characteristics and socio-demographics, medical history, pregnancy, and obstetric profiles of pregnant women. Numerical variables between groups will be analyzed using an Independent sample t-test if the data has normal distribution or the Mann Whitney test if the data distribution is not normal. Categorical variables between groups will be analyzed using Chi-square or Fisher test. Differences between birth and 3 months old follow up will be analyzed using Dependent t-tests if the data distribution has normal distribution or Wilcoxon test if the data distribution is not normal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dadiah Pudding | Active Comparator | The mother received 1 cup or 100 g dadiah pudding containing 75-gram dadiah which provide ±260 kcal energy, 6.12g protein, 23.31g fat, 6.49g carbohydrate, and 6.1x 109 CFU/ml lactic acid bacteria. |
|
| Pudding without dadiah | Placebo Comparator | The mother received 1 cup or 100 g pudding without dadiah containing ±75 kcal energy, 0.3g protein, 0.45 g fat, and 16.2g carbohydrate. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dadiah Pudding | Other | Supplementation of Dadiah Pudding to pregnant women. One cup a day for 18-26 weeks of pregnancy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Infant fecal gut microbiota proportion | Relative difference of non-pathogen and pathogen to total bacteria in infant fecal sample | three months |
| Breast milk gut microbiota proportion | Relative difference of non-pathogen and pathogen to total bacteria in infant fecal sample | three months |
| Level of infant fecal secretory Immunoglobulin A | Concentration of secretory Immunoglobulin A in infant fecal sample | three months |
| Level of breastmilk secretory Immunoglobulin A | Concentration of secretory Immunoglobulin A in breastmilk sample | three months |
| Measure | Description | Time Frame |
|---|---|---|
| Weight increment | Change in body's relative mass of the child measured by subtract child weight at three months old to child weight in the first week | three months |
| Length increment | Change in distance from the bottom of the feet to the top of the head in child's body fully extended and feet flexed measured by subtract child weight at three months old to child length in the first week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zuhrah Taufiqa, MD | Indonesia University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zuhrah Taufiqa | Padang | West Sumatra | 25144 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Rinita Amelia, Koshy Philip, Yudha Endra Pratama EP. Characterization and probiotic potential of lactic acid bacteria isolated from dadiah sampled in West Sumatra. Food Sci Technol. 2020 | ||
| Background | Taufiqa Z, Chandra DN, Helmizar H, Lipoeto NI, Hegar B. Micronutrient Content and Total Lactic Acid Bacteria of Dadiah Pudding as Food Supplementation for Pregnant Women. 2021;9:1149-55 | ||
| 17388062 | Result | Collado MC, Surono IS, Meriluoto J, Salminen S. Potential probiotic characteristics of Lactobacillus and Enterococcus strains isolated from traditional dadih fermented milk against pathogen intestinal colonization. J Food Prot. 2007 Mar;70(3):700-5. doi: 10.4315/0362-028x-70.3.700. | |
| 26715081 |
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Participants are randomly assigned to two groups; the intervention group that received dadiah pudding and the control group that received pudding without dadiah in parallel for the duration of the study.
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| Pudding without Dadiah | Other | Supplementation of Milk Pudding without dadiah to pregnant women. One cup a day for 18-26 weeks of pregnancy |
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| three months |
| Head circumferences increment | Change in the circumference of the distance from above the eyebrows and ears and around the back of the head as a parameter in evaluate nutritional status measured by subtract child head circumference at three months old to child head circumference in the first week | three months |
| Result |
| Surono IS. Traditional Indonesian dairy foods. Asia Pac J Clin Nutr. 2015;24 Suppl 1:S26-30. doi: 10.6133/apjcn.2015.24.s1.05. |
| 25183688 | Result | Surono IS, Martono PD, Kameo S, Suradji EW, Koyama H. Effect of probiotic L. plantarum IS-10506 and zinc supplementation on humoral immune response and zinc status of Indonesian pre-school children. J Trace Elem Med Biol. 2014 Oct;28(4):465-9. doi: 10.1016/j.jtemb.2014.07.009. Epub 2014 Aug 2. |
| 29855271 | Result | Mantaring J, Benyacoub J, Destura R, Pecquet S, Vidal K, Volger S, Guinto V. Effect of maternal supplement beverage with and without probiotics during pregnancy and lactation on maternal and infant health: a randomized controlled trial in the Philippines. BMC Pregnancy Childbirth. 2018 May 31;18(1):193. doi: 10.1186/s12884-018-1828-8. |
| 31991429 | Result | Robertson RC. The Gut Microbiome in Child Malnutrition. Nestle Nutr Inst Workshop Ser. 2020;93:133-144. doi: 10.1159/000503352. Epub 2020 Jan 28. |
| 30559747 | Result | Swartwout B, Luo XM. Implications of Probiotics on the Maternal-Neonatal Interface: Gut Microbiota, Immunomodulation, and Autoimmunity. Front Immunol. 2018 Dec 3;9:2840. doi: 10.3389/fimmu.2018.02840. eCollection 2018. |
| 31380297 | Result | Chen Y, Li Z, Tye KD, Luo H, Tang X, Liao Y, Wang D, Zhou J, Yang P, Li Y, Su Y, Xiao X. Probiotic Supplementation During Human Pregnancy Affects the Gut Microbiota and Immune Status. Front Cell Infect Microbiol. 2019 Jul 16;9:254. doi: 10.3389/fcimb.2019.00254. eCollection 2019. |
| 27801789 | Result | Baldassarre ME, Di Mauro A, Mastromarino P, Fanelli M, Martinelli D, Urbano F, Capobianco D, Laforgia N. Administration of a Multi-Strain Probiotic Product to Women in the Perinatal Period Differentially Affects the Breast Milk Cytokine Profile and May Have Beneficial Effects on Neonatal Gastrointestinal Functional Symptoms. A Randomized Clinical Trial. Nutrients. 2016 Oct 27;8(11):677. doi: 10.3390/nu8110677. |
| 29022387 | Result | Prakoeswa CRS, Herwanto N, Prameswari R, Astari L, Sawitri S, Hidayati AN, Indramaya DM, Kusumowidagdo ER, Surono IS. Lactobacillus plantarum IS-10506 supplementation reduced SCORAD in children with atopic dermatitis. Benef Microbes. 2017 Oct 13;8(5):833-840. doi: 10.3920/BM2017.0011. Epub 2017 Oct 12. |
| 24912386 | Result | Hill C, Guarner F, Reid G, Gibson GR, Merenstein DJ, Pot B, Morelli L, Canani RB, Flint HJ, Salminen S, Calder PC, Sanders ME. Expert consensus document. The International Scientific Association for Probiotics and Prebiotics consensus statement on the scope and appropriate use of the term probiotic. Nat Rev Gastroenterol Hepatol. 2014 Aug;11(8):506-14. doi: 10.1038/nrgastro.2014.66. Epub 2014 Jun 10. |
| ID | Term |
|---|---|
| D006130 | Growth Disorders |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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