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
Verified date | December 2021 |
Source | Andalas University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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.) |
Country | Name | City | State |
---|---|---|---|
Indonesia | Zuhrah Taufiqa | Padang | West Sumatra |
Lead Sponsor | Collaborator |
---|---|
Andalas University | Indonesia University |
Indonesia,
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
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 |
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