Microbial Community in Breast Milk Clinical Trial
Official title:
Evaluation of Microbial Composition in Human Milk From Healthy Women in the Turkish Population: an Observational Cross-sectional Study
| Verified date | August 2019 |
| Source | Hacettepe University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | July 5, 2019 |
| Est. primary completion date | September 5, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 20 Years to 31 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Turkey | Hacettepe University | Ankara |
| Lead Sponsor | Collaborator |
|---|---|
| Hacettepe University | Turkish Society of Clinical Entral & Parenteral Nutrition |
Turkey,
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. — View 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. — View 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. Review. — View Citation
Hunt KM, Foster JA, Forney LJ, Schütte 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 — View 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. — View 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/s — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Microbial abundance and diversity | The microbial composition of the breast milk samples was determined by 16S rRNA (ribosomal ribonucleic acid) gene sequencing analysis. | at 16 day postpartum |