Storage Conditions and Breast Milk Microbiota Composition

NCT05669690 | Unknown

• 1 other identifier: 39040
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Milk Collection; Microbial Colonization

Keywords

breast milk; storage conditions; microbiota

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Fresh breast milk

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.

Breast milk stored at +4'C for 3 days

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.

Breast milk stored at -20'C for 3 months

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.

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy young mothers who had vaginal delivery at least one week ago will be included

You may qualify if:

• Women who had vaginal delivery
• Women who gave delivery at gestational age above 37 weeks
• Women who have a child older than 1 weeks of age
• Mothers with a body mass index between 18.5-25
• Women who gave consent

You may not qualify if:

• Women who had cesarean delivery
• Women who gave premature delivery (\<37 weeks of gestation)
• Women who gave birth within prior 7 days
• Women with premature rupture of membranes
• Women with chorioamnionitis
• Women who had antibiotherapy within last 1 week
• Presence of mastitis
• Presence of maternal co-morbid diseases such as; pregestational diabetes, pregestational hypertension, connective tissue diseases, inflammatory bowel syndrome, solid organ transplantation
• Presence of evidenced congenital infections
• Women who didn't give consent

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University Istanbul Medical Faculty

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 34274151 BACKGROUND

• 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.

  PMID: 32915767 BACKGROUND

• 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.

  PMID: 30473683 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Breast milk

MeSH Terms

Conditions

Breast Milk Expression; Communicable Diseases

Condition Hierarchy (Ancestors)

Breast Feeding; Feeding Behavior; Behavior; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Emine Asuman Coban, Professor

  Istanbul University

  PRINCIPAL INVESTIGATOR

• Elmas Zeynep Ince, Professor

  Istanbul University

  PRINCIPAL INVESTIGATOR

• Bülent Saka, Professor

  Istanbul University

  PRINCIPAL INVESTIGATOR

• Leyla Bilgin, Professor

  Istanbul University

  PRINCIPAL INVESTIGATOR

• Dilek Sever Kaya, Dr Biologist

  Istanbul University

  PRINCIPAL INVESTIGATOR

• Aslı Berru Arslan, Med Student

  Istanbul University

  PRINCIPAL INVESTIGATOR

• Beril Yasa, Ass. Prof.

  Istanbul University

  STUDY DIRECTOR

Central Study Contacts

Beril YASA, Ass. Prof.

CONTACT

+905327920703; beril.yasa@istanbul.edu.tr

Elmas Zeynep Ince, Professor

CONTACT

+90532 344 87 43; elmas.ince@istanbul.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 3, 2023
• Study Start: May 12, 2023
• Primary Completion: September 15, 2023
• Study Completion: December 14, 2024
• Last Updated: May 19, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Data about Clinical Study Report will become available after all samples are obtained, analyzed and study completed. The data will be available for 12 months period.
• Access Criteria: The IPD will be uploaded to the registration system, any investigator will be able to access IPD

Locations

TU (1)