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

NCT05140928 | Completed DMC

• 2 other identifiers: III/UN.16.2/KEP-FK/2020NKB3239/UN2.RST/HKP.05.00/2020
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (3)

• Weight increment

  three months

• Length increment

  three months

• Head circumferences increment

  three months

Study Arms (2)

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.

Other: Dadiah Pudding

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.

Other: Pudding without Dadiah

Interventions

Dadiah Pudding OTHER

Supplementation of Dadiah Pudding to pregnant women. One cup a day for 18-26 weeks of pregnancy

Also known as: Minangkabau Yogurt Pudding

Dadiah Pudding

Pudding without Dadiah OTHER

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

Also known as: Milk Pudding

Pudding without dadiah

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Andalas University: lead
• Indonesia University: collaborator

Study Sites (1)

Zuhrah Taufiqa

Padang, West Sumatra, 25144, Indonesia

Location

Related Publications (12)

• 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

  BACKGROUND

• 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.

  PMID: 17388062 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.

  PMID: 26715081 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.

  PMID: 25183688 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.

  PMID: 29855271 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.

  PMID: 31991429 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.

  PMID: 30559747 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.

  PMID: 31380297 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.

  PMID: 27801789 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.

  PMID: 29022387 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.

  PMID: 24912386 RESULT

MeSH Terms

Conditions

Growth Disorders

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zuhrah Taufiqa, MD

  Indonesia University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: December 2, 2021
• Study Start: August 20, 2020
• Primary Completion: September 9, 2021
• Study Completion: September 9, 2021
• Last Updated: December 2, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)