The Role of Human Milk in Development of Breast Fed Child's Intestinal Microbiota
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Ljubljana
- Enrollment
- 294
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
Brief Summary
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.
Detailed Description
The main goal of the proposed study is to establish the link among mothers' nutrition, human milk LCPUFAs composition and microbiota and their potential influence on child's gut microbiota development. Since the information about the mothers´ diet, about the microbiota and fatty acids composition of human milk, about the faecal microbiota of infants and about the possible mechanisms of eventual transfer of microorganisms from mother to child will be needed to establish these connections. In addition, the influence of vitamine D levels in maternal blood on the bone mineral density in neonates will be determined in the first year of life. The dietary fatty acid composition of plasma lipids in the blood of pregnant women will be assessed.
Mothers and their respective infants will be recruited in the maternity hospitals in three Slovenian regions: Ljubljana, Murska Sobota and Izola. Pregnant women will be invited to participate in the study by informative leaflets during their first visits in the health care centres or gynaecological clinics. All pregnant women who will express interest to participate and fulfilling the participation criteria will be invited to the introductory meeting where they will be informed about the study and will get during 1-hour course, instructions about the writing of 4-day weighed dietary protocol. The meetings will be carried out in the selected regional maternity hospitals. All volunteers willing to participate in the study will get the possibility to get our opinion about their diet during the pregnancy as well as later, during lactation period. The volunteers pregnant women will be also asked to precisely register every probiotic food product or food supplement which they will eat during the last three months of pregnancy and during 4 weeks after delivery.
Informed consent:
The study will be described to pregnant women by principal investigator and/or co-investigators. Following the explanation, the interested pregnant women will be given a written description of the study and the approved informed consent to sign. One copy of the signed document will be provided to the mother and one copy will be retained in the records of the clinical study.
The mothers and respective infants fulfilling the participation criteria for further research will receive written instructions and especially designed health care diary for follow up child's first year health and performance.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Health and development of a child(The first 12 months post partum)