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

NCT01548313 | Completed

• 1 other identifier: J4 3606 BF-UL My milk
• Study Type: observational
• Target: 294
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Lactation

Keywords

human milk; nutrition; breastfed child; microbiota; fatty acids; intestinal microbiota; probiotics

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  from 27th-28th week of pregnancy to 12th-14th week post partum

Secondary Outcomes (1)

• Health and development of a child

  The first 12 months post partum

Study Arms (3)

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.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• autoimmune chronic diseases
• acute and chronic infections
• increased risk for premature delivery

Sponsors & Collaborators

• University of Ljubljana: lead
• University Medical Centre Ljubljana: collaborator

Study Sites (1)

University Medical Centre Ljubljana, Division of Paediatrics, Department of Neonatology

Ljubljana, 1000, Slovenia

Location

Related Publications (7)

• Obermajer T, Grabnar I, Benedik E, Tusar T, Robic Pikel T, Fidler Mis N, Bogovic Matijasic B, Rogelj I. Microbes in Infant Gut Development: Placing Abundance Within Environmental, Clinical and Growth Parameters. Sci Rep. 2017 Sep 11;7(1):11230. doi: 10.1038/s41598-017-10244-x.

  PMID: 28894126 RESULT

• Obermajer T, Lipoglavsek L, Tompa G, Treven P, Lorbeg PM, Matijasic BB, Rogelj I. Correction: Colostrum of Healthy Slovenian Mothers: Microbiota Composition and Bacteriocin Gene Prevalence. PLoS One. 2015 Jun 29;10(6):e0132201. doi: 10.1371/journal.pone.0132201. eCollection 2015. No abstract available.

  PMID: 26120836 RESULT

• Soltirovska Salamon A, Benedik E, Bratanic B, Velkavrh M, Rogelj I, Fidler Mis N, Bogovic Matijasic B, Paro-Panjan D. Vitamin D Status and Its Determinants in Healthy Slovenian Pregnant Women. Ann Nutr Metab. 2015;67(2):96-103. doi: 10.1159/000439093. Epub 2015 Sep 5.

  PMID: 26340437 RESULT

• Benedik E, Korousic Seljak B, Hribar M, Rogelj I, Bratanic B, Orel R, Fidler Mis N. Comparison of a Web-Based Dietary Assessment Tool with Software for the Evaluation of Dietary Records. Zdr Varst. 2015 Mar 13;54(2):91-7. doi: 10.1515/sjph-2015-0014. eCollection 2015 Jun.

  PMID: 27646914 RESULT

• Benedik E, Korousic Seljak B, Simcic M, Rogelj I, Bratanic B, Ding EL, Orel R, Fidler Mis N. Comparison of paper- and web-based dietary records: a pilot study. Ann Nutr Metab. 2014;64(2):156-66. doi: 10.1159/000363336. Epub 2014 Aug 9.

  PMID: 25116257 RESULT

• Robic T, Benedik E, Fidler Mis N, Bratanic B, Rogelj I, Golja P. Challenges in determining body fat in pregnant women. Ann Nutr Metab. 2013;63(4):341-9. doi: 10.1159/000358339. Epub 2014 Mar 6.

  PMID: 24603563 RESULT

• Obermajer T, Pogacic T. Commentary: Relationship between Milk Microbiota, Bacterial Load, Macronutrients, and Human Cells during Lactation. Front Microbiol. 2016 Aug 17;7:1281. doi: 10.3389/fmicb.2016.01281. eCollection 2016. No abstract available.

  PMID: 27581429 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Irena Rogelj, Prof.

  University of Ljubljana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2012
• First Posted: March 8, 2012
• Study Start: May 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2015
• Last Updated: May 1, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)