The Role of Human Milk in Development of Breast Fed Child's Intestinal Microbiota (MYMILK)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University Medical Centre Ljubljana
Information provided by (Responsible Party):
University of Ljubljana
ClinicalTrials.gov Identifier:
NCT01548313
First received: March 5, 2012
Last updated: February 4, 2013
Last verified: February 2013
  Purpose

The ideal food for normal infants is human milk. In addition, breast milk has been shown to be a continuous source of commensal, and⁄or probiotic bacteria to the infant gut where they play a key role in the initiation and development of the gut microbiota. Intestinal colonization is essential for maturation of the gut-associated lymphoid tissue (GALT) and the homeostasis of the intestinal epithelium. Colonization begins immediately after birth, while later the composition of the gut microbiota is affected by feeding practices. Results of some studies suggest that long-chain polyunsaturated fatty acids (LCPUFAs) promote the adhesion of probiotics to mucosal surfaces and along with probiotic bacteria contribute to the regulation of innate and adaptive immune responses and present a link among mother's diet, and microbes. The main purpose of the proposed research is to establish the link among mothers' nutrition, human milk LCPUFAs composition and microbiota and their potential influence on child's gut microbiota development. Pregnant women from three different regions of Slovenia will be involved into the study. Dietary intakes will be assessed during pregnancy, at the beginning of the 3rd trimester of pregnancy, and during lactation, at 4 weeks post partum, by 7-day weighed dietary protocol (7DP). Human milk (colostrum, and mature human milk) and infant's faeces will be sampled twice: at 2 or 3rd day post partum (meconium) and at 4 weeks post partum for the determination of human milk LCPUFAs composition and the assessment of human milk (colostrum und mature) and faeces microbiota. The fatty acid composition of human milk will be analysed by capillary gas-liquid chromatography (GC). Microbiota of milk and faeces will be studied using conventional microbiological and modern molecular approach such as qualitative and quantitative PCR amplification of informative genomic regions, DGGE/TGGE and/or t-RFLP and sequencing. Regular monthly meetings with the researchers will be organised for discussion and advising. Basic health parameters of infants will be followed. Data will be gathered from maternity department medical charts, from regular paediatric health care visits and from especially designed health care diary each mother will keep until the end of her child's first year.


Condition
Pregnancy
Lactation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Human Milk in Development of Breast Fed Child's Intestinal Microbiota

Resource links provided by NLM:


Further study details as provided by University of Ljubljana:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Health and development of a child [ Time Frame: The first 12 months post partum ] [ Designated as safety issue: Yes ]
    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

colostrum, meconium, milk, child's faeces, urine, venous blood


Estimated Enrollment: 300
Study Start Date: May 2010
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Slovenian, otherwise healthy pregnant women, plan to fully breastfeed their baby for at least 6 weeks, willingness to write a 7-day weighted dietary protocol (7DP) twice: during pregnancy and again at 4 weeks post partum.

Criteria

Inclusion Criteria:

  • healthy pregnant women
  • living in Slovenia
  • intend to fully breast-feed their babies at least 6 weeks after delivery
  • willing to write a 4-day weighted dietary protocol (7DP) twice: during pregnancy and again at 4 weeks post partum

Exclusion Criteria:

  • autoimmune chronic diseases
  • acute and chronic infections
  • increased risk for premature delivery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01548313

Locations
Slovenia
University Medical Centre Ljubljana, Division of Paediatrics, Department of Neonatology
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
University of Ljubljana
University Medical Centre Ljubljana
Investigators
Principal Investigator: Irena Rogelj, Prof. University of Ljubljana, Biotechnical faculty
  More Information

Additional Information:
No publications provided

Responsible Party: University of Ljubljana
ClinicalTrials.gov Identifier: NCT01548313     History of Changes
Other Study ID Numbers: J4 3606 BF-UL My milk
Study First Received: March 5, 2012
Last Updated: February 4, 2013
Health Authority: Slovenia: Ethics Committee

Keywords provided by University of Ljubljana:
human milk
nutrition
breastfed child
microbiota
fatty acids
intestinal microbiota
probiotics

ClinicalTrials.gov processed this record on July 26, 2014