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The Effect of Storage Conditions on Microbiota Composition of Breast Milk
Sponsor study identifier
observational
20
1 country
1
Study Start
May 12, 2023
Actual (reported)Primary Completion
September 15, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 14, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Breast milk is the mainstay of newborn nutrition, providing all the nutrients and vitamins necessary for optimal growth of newborn infants. Beside its nutritional properties, breast milk also contains bioactive factors such as soluble immune factors, antimicrobial proteins, functional fatty acids, hormones, oligosaccharides, stem cells and microbiota. Although fresh breast milk is the optimal source of nutrition for newborn infants, breast milk must be expressed and stored in some conditions. Breast milk was thought to be sterile for many years. This idea has changed with the isolation of live bacteria in the breast milk of healthy mothers in the recent past. Thus, it has been shown that breast milk is not actually a sterile body fluid, but has a microbiota of its own. This study aimed to examine the effect of storage conditions of breast milk at different temperatures on the microbial composition of the breast milk. The prospective experimental study will be conducted under the supervision of Istanbul University, Istanbul Medical Faculty, Department of Pediatrics, Neonatology Department. Informed consent of mothers will be taken. Thirty mililiter (30 mL) breast milk that was obtained from volunteer mothers will be divided into 3 samples, each 10 mL of breast milk will be stored at different temperatures. Ten mililiter will be studied for microbial composition with 16S rRNA amplicon sequencing and bioinformatics analysis immediately, 10 mL will be stored at +4'C for 3 days and will be studied at the end of 3rd day, other 10 mL will be stored at -20'C for 3 months and will be studied at the end of 3rd months. 16S rRNA amplicon sequencing and bioinformatic analysis studies will be performed at Istanbul Medical Faculty Clinical Nutrition and Microbiota Research Laboratory. This present study is planned to be carried out for 24 months between January 2023 and December 2024
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 14, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 20, 2022
Actual (reported)January 3, 2023
Actual (reported)May 12, 2023
Actual (reported)September 15, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 14, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Changes in microbiota composition of breast milk after storage
To evaluate the effects of different storage conditions on microbiota composition of breast milk
24 months
Fresh breast milk obtained from volunteer mothers will be divided into four parts. Fresh breast milk will be studied for microbiota composition immediately within 3 hours.
One part of previously obtained fresh breast milk will be stored at +4'C at refrigerator for 3 days long, then microbiota composition will be studied.
Last part of the same breast milk specimen will be freezed at -20'C for 3 months and microbiota composition of the 3 months frozen milk will be studied.
Healthy young mothers who had vaginal delivery at least one week ago will be included
Istanbul University Istanbul Medical Faculty
Istanbul, Turkey (Türkiye)
Selma-Royo M, Calvo Lerma J, Cortes-Macias E, Collado MC. Human milk microbiome: From actual knowledge to future perspective. Semin Perinatol. 2021 Oct;45(6):151450. doi: 10.1016/j.semperi.2021.151450. Epub 2021 Jun 16.
Pandya SP, Doshi H, Codipilly CN, Fireizen Y, Potak D, Schanler RJ. Bacterial stability with freezer storage of human milk. J Perinat Med. 2020 Sep 14;49(2):225-228. doi: 10.1515/jpm-2020-0131. Print 2021 Feb 23.
Breast milk
Emine Asuman Coban, Professor
Istanbul University
Elmas Zeynep Ince, Professor
Istanbul University
Bülent Saka, Professor
Istanbul University
Leyla Bilgin, Professor
Istanbul University
First Submitted
December 20, 2022
First Posted
January 3, 2023
Study Start
May 12, 2023
Actual (reported)Primary Completion
September 15, 2023
Estimated (date passed)Contact the study team to confirm eligibility.
Fernandez L, Ruiz L, Jara J, Orgaz B, Rodriguez JM. Strategies for the Preservation, Restoration and Modulation of the Human Milk Microbiota. Implications for Human Milk Banks and Neonatal Intensive Care Units. Front Microbiol. 2018 Nov 9;9:2676. doi: 10.3389/fmicb.2018.02676. eCollection 2018.
Dilek Sever Kaya, Dr Biologist
Istanbul University
Aslı Berru Arslan, Med Student
Istanbul University
Beril Yasa, Ass. Prof.
Istanbul University
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 14, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 19, 2023
Record last verified: 2023-05
It is planned to share individual participant data in terms of changes in microbiota composition of breast milk with different storage conditions. Special data about identity of participants will be kept blinded.
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Source: ClinicalTrials.gov.
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