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

Primary Purpose

Gastrointestinal Microbiome, Immunoglobulin A, Growth; Stunting, Nutritional

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Dadiah Pudding
Pudding without Dadiah
Sponsored by
Andalas University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gastrointestinal Microbiome focused on measuring dadiah, local yogurt, Minangkabau yogurt, pregnant women, dietary supplement, gut microbiota, immunoglobulin A, gastrointestinal health, fermented dairy product, lactic acid bacteria, child growth, probiotic

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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.)

Sites / Locations

  • Zuhrah Taufiqa

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dadiah Pudding

Pudding without dadiah

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Infant fecal gut microbiota proportion
Relative difference of non-pathogen and pathogen to total bacteria in infant fecal sample
Breast milk gut microbiota proportion
Relative difference of non-pathogen and pathogen to total bacteria in infant fecal sample
Level of infant fecal secretory Immunoglobulin A
Concentration of secretory Immunoglobulin A in infant fecal sample
Level of breastmilk secretory Immunoglobulin A
Concentration of secretory Immunoglobulin A in breastmilk sample

Secondary Outcome Measures

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
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
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

Full Information

First Posted
November 18, 2021
Last Updated
December 1, 2021
Sponsor
Andalas University
Collaborators
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT05140928
Brief Title
The Effect of Maternal Dadiah Supplementation During Pregnancy on Child Growth and Gastrointestinal Health Outcomes
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
August 20, 2020 (Actual)
Primary Completion Date
September 9, 2021 (Actual)
Study Completion Date
September 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Andalas University
Collaborators
Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Microbiome, Immunoglobulin A, Growth; Stunting, Nutritional
Keywords
dadiah, local yogurt, Minangkabau yogurt, pregnant women, dietary supplement, gut microbiota, immunoglobulin A, gastrointestinal health, fermented dairy product, lactic acid bacteria, child growth, probiotic

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dadiah Pudding
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Pudding without dadiah
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dadiah Pudding
Other Intervention Name(s)
Minangkabau Yogurt Pudding
Intervention Description
Supplementation of Dadiah Pudding to pregnant women. One cup a day for 18-26 weeks of pregnancy
Intervention Type
Other
Intervention Name(s)
Pudding without Dadiah
Other Intervention Name(s)
Milk Pudding
Intervention Description
Supplementation of Milk Pudding without dadiah to pregnant women. One cup a day for 18-26 weeks of pregnancy
Primary Outcome Measure Information:
Title
Infant fecal gut microbiota proportion
Description
Relative difference of non-pathogen and pathogen to total bacteria in infant fecal sample
Time Frame
three months
Title
Breast milk gut microbiota proportion
Description
Relative difference of non-pathogen and pathogen to total bacteria in infant fecal sample
Time Frame
three months
Title
Level of infant fecal secretory Immunoglobulin A
Description
Concentration of secretory Immunoglobulin A in infant fecal sample
Time Frame
three months
Title
Level of breastmilk secretory Immunoglobulin A
Description
Concentration of secretory Immunoglobulin A in breastmilk sample
Time Frame
three months
Secondary Outcome Measure Information:
Title
Weight increment
Description
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
Time Frame
three months
Title
Length increment
Description
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
Time Frame
three months
Title
Head circumferences increment
Description
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
Time Frame
three months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zuhrah Taufiqa, MD
Organizational Affiliation
Indonesia University
Official's Role
Study Director
Facility Information:
Facility Name
Zuhrah Taufiqa
City
Padang
State/Province
West Sumatra
ZIP/Postal Code
25144
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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Results Reference
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Results Reference
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17388062
Citation
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Citation
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The Effect of Maternal Dadiah Supplementation During Pregnancy on Child Growth and Gastrointestinal Health Outcomes

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