The Role of Human Milk in Development of Breast Fed Child's Intestinal Microbiota (MYMILK)
|ClinicalTrials.gov Identifier: NCT01548313|
Recruitment Status : Unknown
Verified January 2015 by University of Ljubljana.
Recruitment status was: Active, not recruiting
First Posted : March 8, 2012
Last Update Posted : February 2, 2015
|Condition or disease|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||The Role of Human Milk in Development of Breast Fed Child's Intestinal Microbiota|
|Study Start Date :||May 2010|
|Primary Completion Date :||May 2013|
|Estimated Study Completion Date :||May 2015|
Pregnant women from Ljubljana region
Women at 3rd trimester of pregnancy living in the Ljubljana region.
Pregnant women from Izola region
Women at 3rd trimester of pregnancy living in the Izola region.
Pregnant women from Murska Sobota region
Women at 3rd trimester of pregnancy living in the Murska Sobota region.
- Effect of nutrition patterns of pregnant and lactating women on fatty acid composition of milk and plasma lipids, vitemine D in blood, bone density and composition of microbiota of colostrum, milk, meconium and child's faeces [ Time Frame: from 27th-28th week of pregnancy to 12th-14th week post partum ]Nutrition patterns of pregnant and lactating women will be assessed by 4-day weighed dietary protocol (27.-28. week of pregnancy and 4 weeks after delivery). Fatty acids composition of milk, will be determined 4 weeks post partum and between 12th and 14th week post partum. Microbial composition of human colostrum, milk, child's meconium and faeces with emphasis on bifidobacteria and lactic acid bacteria will be determined 2nd- 3rd day post partum, at 4 weeks post partum and 12th-14th week post partum). The vitamin D and fatty acids in blood will be determined at 27th-37th week of pregnancy.
- Health and development of a child [ Time Frame: The first 12 months post partum ]Growth, type of nutrition, development and health status will be observed. The babies will be examined six times: at birth, at 1st month (between 28th and 38th day), at 3rd month (between 80th and 100th day), at 6th month (between 110th and 130th day), at 9th month (between 260th and 280th day) and at 12th month (between 355th and 375th day).The bone density will be determined at birth and at 1st, 3rd and 12th months.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01548313
|University Medical Centre Ljubljana, Division of Paediatrics, Department of Neonatology|
|Ljubljana, Slovenia, 1000|
|Principal Investigator:||Irena Rogelj, Prof.||University of Ljubljana, Biotechnical faculty|