Clinical trial NCT04072627: Microbial Composition of Breast Milk Collected From Healthy Turkish Women
Official title: Evaluation of Microbial Composition in Human Milk From Healthy Women in the Turkish Population: an Observational Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Microbial Community in Breast Milk
Keywords: breast milk
microbiota
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: Turkish Society of Clinical Entral & Parenteral Nutrition
First posted: 2019-08-28
Enrollment: 20
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 31
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 20 healthy women who were at 16. day postpartum

Brief summary: Breast milk is an optimal source of nutrients for newborns as well as a potential source of bacteria for the intestinal microbiota. However, there are limited number of studies evaluating the relationship between maternal nutrition, breast milk and neonatal intestinal microbiota.

Detailed description: The study was conducted on a total of 20 healthy women following at Obstetrics and Gynecology Department of Gülhane Education and Research Hospital in Ankara Health Sciences University. Sociodemographic characteristics, anthropometric measurements, breastfeeding characteristics were evaluated in the third trimester of the women who underwent routine prenatal care. Breast milk samples were obtained at 16.day postpartum during lactation.

Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy
* Age 19-35 years
* At weeks of 30-36 gestation
* No history of acute or chronic diseases
* Term delivery

Exclusion Criteria:

* Alcohol use
* Smoking
* Gestational diabetes
* Type 1 and 2 diabetes
* Preeclampsia
* Polycystic ovary
* Syndrome
* Thyroid and parathyroid disease
* Metabolic bone or kidney disease
* Abnormal liver function
* Multiple pregnancy
* Premature and postmature labor
* Having chemotherapy
* Taking drugs such as antibiotics and probiotics

Primary outcomes:
measure: Microbial abundance and diversity
timeFrame: at 16 day postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Gülhan SAMUR, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Murphy K, Curley D, O'Callaghan TF, O'Shea CA, Dempsey EM, O'Toole PW, Ross RP, Ryan CA, Stanton C. The Composition of Human Milk and Infant Faecal Microbiota Over the First Three Months of Life: A Pilot Study. Sci Rep. 2017 Jan 17;7:40597. doi: 10.1038/srep40597.
citation: Fitzstevens JL, Smith KC, Hagadorn JI, Caimano MJ, Matson AP, Brownell EA. Systematic Review of the Human Milk Microbiota. Nutr Clin Pract. 2017 Jun;32(3):354-364. doi: 10.1177/0884533616670150. Epub 2016 Sep 27.
citation: Jost T, Lacroix C, Braegger C, Chassard C. Assessment of bacterial diversity in breast milk using culture-dependent and culture-independent approaches. Br J Nutr. 2013 Oct;110(7):1253-62. doi: 10.1017/S0007114513000597. Epub 2013 Mar 14.
citation: Hunt KM, Foster JA, Forney LJ, Schutte UM, Beck DL, Abdo Z, Fox LK, Williams JE, McGuire MK, McGuire MA. Characterization of the diversity and temporal stability of bacterial communities in human milk. PLoS One. 2011;6(6):e21313. doi: 10.1371/journal.pone.0021313. Epub 2011 Jun 17.
citation: Chen PW, Lin YL, Huang MS. Profiles of commensal and opportunistic bacteria in human milk from healthy donors in Taiwan. J Food Drug Anal. 2018 Oct;26(4):1235-1244. doi: 10.1016/j.jfda.2018.03.004. Epub 2018 Apr 5.
citation: Damaceno QS, Souza JP, Nicoli JR, Paula RL, Assis GB, Figueiredo HC, Azevedo V, Martins FS. Evaluation of Potential Probiotics Isolated from Human Milk and Colostrum. Probiotics Antimicrob Proteins. 2017 Dec;9(4):371-379. doi: 10.1007/s12602-017-9270-1.