Microbial Community in Breast MilkNCT04072627
Microbial Composition of Breast Milk Collected From Healthy Turkish Women
An observational study of Microbial Community in Breast Milk, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 31 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Microbial Community in Breast Milk
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2018to 5 Jul 2019
- 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 20 to 31 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 20 healthy women who were at 16. day postpartum
Who may be able to join
- Singleton pregnancy
- Age 19-35 years
- At weeks of 30-36 gestation
- No history of acute or chronic diseases
- Term delivery
Who cannot join
- Alcohol use
- Smoking
- Gestational diabetes
- Type 1 and 2 diabetes
- Preeclampsia
- Polycystic ovary
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Microbial Composition in Human Milk From Healthy Women in the Turkish Population: an Observational Cross-sectional Study
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.
Read the 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.
- Conditions
- Microbial Community in Breast Milk
- Keywords
- breast milk, microbiota
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbial abundance and diversity
The microbial composition of the breast milk samples was determined by 16S rRNA (ribosomal ribonucleic acid) gene sequencing analysis.
Measured: at 16 day postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start5 May 2018
- Primary completion5 Sep 2018
- Study completion5 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Microbial Community in Breast MilkStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Turkish Society of Clinical Enteral and Parenteral Nutrition
- Responsible party
- Principal investigator, F. Gülhan Samur, Hacettepe University
- Investigators
- Gülhan SAMUR, Professor, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04072627
- Sponsor's protocol ID
- Hacettepe Nutrition Diet
- Status last verified
- Aug 2019
- First submitted
- 27 Aug 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28094284Fitzstevens 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.
PubMed 27679525Jost 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.
PubMed 23507238Hunt 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.
PubMed 21695057Chen 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.
PubMed 30249322Damaceno 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.
PubMed 28374172
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Microbial Composition in Human Milk From Healthy Women in the Turkish Population: an Observational Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04072627
- Acronym / sponsor ID
- Hacettepe Nutrition Diet
- Conditions
- Microbial Community in Breast Milk
- Keywords
- breast milk, microbiota
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Turkish Society of Clinical Enteral and Parenteral Nutrition
- Study start
- 5 May 2018 (actual)
- Primary completion
- 5 Sep 2018 (actual)
- Study completion
- 5 Jul 2019 (actual)
- First posted
- 28 Aug 2019 (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 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 31 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 20 healthy women who were at 16. day postpartum
Key inclusion criteria (5 listed)
- Singleton pregnancy
- Age 19-35 years
- At weeks of 30-36 gestation
- No history of acute or chronic diseases
- Term delivery
Key exclusion criteria (14 listed)
- Alcohol use
- Smoking
- Gestational diabetes
- Type 1 and 2 diabetes
- Preeclampsia
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
Microbial abundance and diversity
Time frame: at 16 day postpartum
The microbial composition of the breast milk samples was determined by 16S rRNA (ribosomal ribonucleic acid) gene sequencing analysis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Results publication: PubMed 28094284Murphy 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.
- Results publication: PubMed 27679525Fitzstevens 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.
- Results publication: PubMed 23507238Jost 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.
- Results publication: PubMed 21695057Hunt 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.
- Results publication: PubMed 30249322Chen 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.
- Results publication: PubMed 28374172Damaceno 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.
- Individual participant dataSharing planned: No
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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.
Gülhan SAMUR, Professor principal investigator
Hacettepe 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 Microbial Community in Breast Milk, run by Hacettepe 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 14 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: finished, as of the sponsor's last update on 28 Aug 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbial abundance and diversity (time frame: at 16 day postpartum). 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 NCT04072627, which also lists 6 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 28 Aug 2019.