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

December 1, 2021 updated by: Zuhrah Taufiqa, Andalas University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • West Sumatra
      • Padang, West Sumatra, Indonesia, 25144
        • Zuhrah Taufiqa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dadiah Pudding
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.
Other: Dadiah Pudding
Supplementation of Dadiah Pudding to pregnant women. One cup a day for 18-26 weeks of pregnancy
Other Names:
  • Minangkabau Yogurt Pudding
Placebo Comparator: Pudding without dadiah
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.
Other: Pudding without Dadiah
Supplementation of Milk Pudding without dadiah to pregnant women. One cup a day for 18-26 weeks of pregnancy
Other Names:
  • Milk Pudding

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant fecal gut microbiota proportion
Time Frame: three months
Relative difference of non-pathogen and pathogen to total bacteria in infant fecal sample
three months
Breast milk gut microbiota proportion
Time Frame: three months
Relative difference of non-pathogen and pathogen to total bacteria in infant fecal sample
three months
Level of infant fecal secretory Immunoglobulin A
Time Frame: three months
Concentration of secretory Immunoglobulin A in infant fecal sample
three months
Level of breastmilk secretory Immunoglobulin A
Time Frame: three months
Concentration of secretory Immunoglobulin A in breastmilk sample
three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight increment
Time Frame: three months
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
Time Frame: three months
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
Head circumferences increment
Time Frame: three months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andalas University

Collaborators

Indonesia University

Investigators

  • Study Director: Zuhrah Taufiqa, MD, Indonesia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2020

Primary Completion (Actual)

September 9, 2021

Study Completion (Actual)

September 9, 2021

Study Registration Dates

First Submitted

November 18, 2021

First Submitted That Met QC Criteria

December 1, 2021

First Posted (Actual)

December 2, 2021

Study Record Updates

Last Update Posted (Actual)

December 2, 2021

Last Update Submitted That Met QC Criteria

December 1, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • III/UN.16.2/KEP-FK/2020
  • NKB3239/UN2.RST/HKP.05.00/2020 (Other Grant/Funding Number: PUTI Grant by Universitas Indonesia)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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