Breast Milk CollectionNCT05669690
Storage Conditions and Breast Milk Microbiota Composition
An observational study of Breast Milk Collection and Microbial Colonization, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Milk Collection, Microbial Colonization
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 May 2023to 14 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy young mothers who had vaginal delivery at least one week ago will be included
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University Istanbul Medical Faculty
Istanbul
Beril Yasa, MD, 00905327920703, beril.yasa@istanbul.edu.tr
About this study
Official title: The Effect of Storage Conditions on Microbiota Composition of Breast Milk
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.
Read more
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
Read the detailed description
Fresh breast milk is the mainstay of newborn nutrition and provides all the nutrients and vitamins needed for optimal growth of newborn babies. In addition to the nutritional properties of breast milk, there are some bioactive factors such as soluble immune factors, antimicrobial proteins, functional fatty acids, hormones, oligosaccharides, stem cells and microbiota in breast milk. Breastfeeding also strengthens the bond between mother and baby in postpartum period and provides nutrition to the newborn infant. Breast milk improves microbial colonization, improves immune system maturation and supports the metabolic activities of the newborn infant.
Although fresh breast milk is the optimal food source for newborn babies, in some cases, breast milk must be expressed and stored.It is reported that breast milk can be stored in the refrigerator for 3 days without being frozen at +4 degrees Celsius, and can be stored as frozen for 3 months if it is frozen within the first 24 hours after milking. The North American Breast Milk Banking Association, on the other hand, reports that the storage period can be extended up to 12 months at temperatures below -20 degrees Celsius.
While breast milk was thought to be a sterile fluid, this idea has changed with the isolation of live bacteria in the milk of healthy mothers in the recent past. The presence of many bacteria such as Lactobacillus, Lactococcus, Bifidobacterium, Streptococcus, Enterococcus and Staphylococcus has been demonstrated by traditional culture methods of breast milk. The new generation sequencing technologies obtained higher microbial diversity of breast milk and detected mouth-dwelling bacteria such as Veillonella and Prevotella, skin bacteria such as Propionobacterium and gram-negative bacteria such as Pseudomonas, Ralstonia, Klebsiella. Thus, it has been shown that breast milk is not actually a sterile body fluid, but has a microbiota of its own.
There are few studies evaluating the effect of breast milk storage conditions on microbiota. In a study, it was shown that the number of bacterial colonies in breast milk decreased as the freezing period increased. It has been shown that 98-100% of bacteria in frozen breast milk are lost after 12 weeks of storage.
Although studies evaluating fresh breast milk microbiota have been reported in the literature, there are few studies evaluating the effect of milk storage conditions on microbial diversity. In existing studies, microbial growth was ensured by culture method and diversity was defined by traditional microbiological methods. No study was found that evaluated the microbial composition of breast milk with next-generation sequencing based on the 16S rRNA amplicon sequencing strategy.
This study aimed to evaluate how the generally recommended breast milk storage conditions and duration of storage affect the microbiota composition of breast milk. This study will provide new data and new recommendations about storage of breast milk.
- Conditions
- Breast Milk Collection, Microbial Colonization
- Keywords
- breast milk, storage conditions, microbiota
- Medical subject headings
- Breast Milk Expression, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in microbiota composition of breast milk after storage
To evaluate the effects of different storage conditions on microbiota composition of breast milk
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2023
- Study start12 May 2023
- Primary completion15 Sep 2023 (estimated)
- Study completion14 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast Milk CollectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beril Yasa, Istanbul University
- Investigators
- Emine Asuman Coban, Professor, Principal investigator, Istanbul UniversityElmas Zeynep Ince, Professor, Principal investigator, Istanbul UniversityBülent Saka, Professor, Principal investigator, Istanbul UniversityLeyla Bilgin, Professor, Principal investigator, Istanbul UniversityDilek Sever Kaya, Dr Biologist, Principal investigator, Istanbul UniversityAslı Berru Arslan, Med Student, Principal investigator, Istanbul UniversityBeril Yasa, Ass. Prof., Study director, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05669690
- Sponsor's protocol ID
- 39040
- Status last verified
- May 2023
- First submitted
- 20 Dec 2022
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 34274151Pandya 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.
PubMed 32915767Fernandez 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.
PubMed 30473683
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Storage Conditions on Microbiota Composition of Breast Milk
- ClinicalTrials.gov ID
- NCT05669690
- Acronym / sponsor ID
- 39040
- Conditions
- Breast Milk Collection, Microbial Colonization
- Keywords
- breast milk, storage conditions, microbiota
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 12 May 2023 (actual)
- Primary completion
- 15 Sep 2023 (estimated)
- Study completion
- 14 Dec 2024 (estimated)
- First posted
- 3 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Fresh breast milk is the mainstay of newborn nutrition and provides all the nutrients and vitamins needed for optimal growth of newborn babies. In addition to the nutritional properties of breast milk, there are some bioactive factors such as soluble immune factors, antimicrobial proteins, functional fatty acids, hormones, oligosaccharides, stem cells and microbiota in breast milk. Breastfeeding also strengthens the bond between mother and baby in postpartum period and provides nutrition to the newborn infant. Breast milk improves microbial colonization, improves immune system maturation and supports the metabolic activities of the newborn infant.
Although fresh breast milk is the optimal food source for newborn babies, in some cases, breast milk must be expressed and stored.It is reported that breast milk can be stored in the refrigerator for 3 days without being frozen at +4 degrees Celsius, and can be stored as frozen for 3 months if it is frozen within the first 24 hours after milking. The North American Breast Milk Banking Association, on the other hand, reports that the storage period can be extended up to 12 months at temperatures below -20 degrees Celsius.
While breast milk was thought to be a sterile fluid, this idea has changed with the isolation of live bacteria in the milk of healthy mothers in the recent past. The presence of many bacteria such as Lactobacillus, Lactococcus, Bifidobacterium, Streptococcus, Enterococcus and Staphylococcus has been demonstrated by traditional culture methods of breast milk. The new generation sequencing technologies obtained higher microbial diversity of breast milk and detected mouth-dwelling bacteria such as Veillonella and Prevotella, skin bacteria such as Propionobacterium and gram-negative bacteria such as Pseudomonas, Ralstonia, Klebsiella. Thus, it has been shown that breast milk is not actually a sterile body fluid, but has a microbiota of its own.
There are few studies evaluating the effect of breast milk storage conditions on microbiota. In a study, it was shown that the number of bacterial colonies in breast milk decreased as the freezing period increased. It has been shown that 98-100% of bacteria in frozen breast milk are lost after 12 weeks of storage.
Although studies evaluating fresh breast milk microbiota have been reported in the literature, there are few studies evaluating the effect of milk storage conditions on microbial diversity. In existing studies, microbial growth was ensured by culture method and diversity was defined by traditional microbiological methods. No study was found that evaluated the microbial composition of breast milk with next-generation sequencing based on the 16S rRNA amplicon sequencing strategy.
This study aimed to evaluate how the generally recommended breast milk storage conditions and duration of storage affect the microbiota composition of breast milk. This study will provide new data and new recommendations about storage of breast milk.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy young mothers who had vaginal delivery at least one week ago will be included
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in microbiota composition of breast milk after storage
Time frame: 24 months
To evaluate the effects of different storage conditions on microbiota composition of breast milk
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Background: PubMed 34274151Selma-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.
- Background: PubMed 32915767Pandya 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.
- Results publication: PubMed 30473683Fernandez 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.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emine Asuman Coban, Professor principal investigator
Istanbul University
Elmas Zeynep Ince, Professor principal investigator
Istanbul University
Bülent Saka, Professor principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Milk Collection and Microbial Colonization, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beril YASA, Ass. Prof. (+905327920703, beril.yasa@istanbul.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in microbiota composition of breast milk after storage (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05669690, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.