The Effect of Maternal Dadiah Supplementation During Pregnancy on Child Growth and Gastrointestinal Health Outcomes

Gastrointestinal Microbiome Clinical Trial

Official title:

The Effect of Maternal Dadiah (Minangkabau Yogurt) Supplementation During Pregnancy on Child Growth, Gut Microbiota Proportion and the Level of Secretory Immunoglobulin A, in West Sumatra: A Randomised Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05140928
• Other study ID #: III/UN.16.2/KEP-FK/2020
• Secondary ID: NKB3239/UN2.RST/
• Status: Completed
• Phase: N/A
• Start date: August 20, 2020
• Est. completion date: September 9, 2021

Study information

• Verified date: December 2021
• Source: Andalas University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: September 9, 2021
• Est. primary completion date: September 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

• Women with10-20 weeks gestation

• Women give voluntary informed consent

• Women willing to give exclusive breastfeeding

• Women live in an area under study, registered, and visit antenatal care at targeted public health centers

• Women plan to deliver babies in the area under study

Exclusion Criteria:

• Women having a medical history of HIV/AIDS, TBC, Hepatitis B.

• Women with multiple pregnancies

• Women having obesity, and/or another high-risk pregnancy (hypertension, preeclampsia, diabetes, bleeding history)

• Received antibiotic treatment or intentionally consumes probiotic products during the preceding 4 weeks. (If the subject was on antibiotics before the beginning of the study or probiotics, a washout period of 2 weeks is required.)

Related Conditions & MeSH terms

• Gastrointestinal Microbiome
• Growth Disorders
• Growth; Stunting, Nutritional
• Immunoglobulin A

Intervention

Other:
• Dadiah Pudding
Supplementation of Dadiah Pudding to pregnant women. One cup a day for 18-26 weeks of pregnancy
• Pudding without Dadiah
Supplementation of Milk Pudding without dadiah to pregnant women. One cup a day for 18-26 weeks of pregnancy

Locations

Country	Name	City	State
Indonesia	Zuhrah Taufiqa	Padang	West Sumatra

Sponsors (2)

Lead Sponsor	Collaborator
Andalas University	Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (12)

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 Ha — View Citation

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 — View Citation

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. — View Citation

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 sco — View Citation

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. — View Citation

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- — View Citation

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

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. Review. — View Citation

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: 10.101 — View Citation

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. Review. — View Citation

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. Review. — View Citation

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

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infant fecal gut microbiota proportion	Relative difference of non-pathogen and pathogen to total bacteria in infant fecal sample	three months
Primary	Breast milk gut microbiota proportion	Relative difference of non-pathogen and pathogen to total bacteria in infant fecal sample	three months
Primary	Level of infant fecal secretory Immunoglobulin A	Concentration of secretory Immunoglobulin A in infant fecal sample	three months
Primary	Level of breastmilk secretory Immunoglobulin A	Concentration of secretory Immunoglobulin A in breastmilk sample	three months
Secondary	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
Secondary	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	three months
Secondary	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