NCT04072627

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

4 months

First QC Date

August 27, 2019

Last Update Submit

August 27, 2019

Conditions

Microbial Community in Breast Milk

Keywords

breast milkmicrobiota

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age20 Years - 31 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

20 healthy women who were at 16. day postpartum

You may qualify if:

  • Singleton pregnancy
  • Age 19-35 years
  • At weeks of 30-36 gestation
  • No history of acute or chronic diseases
  • Term delivery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 28094284RESULT

  • 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.

    PMID: 27679525RESULT

  • 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.

    PMID: 23507238RESULT

  • Hunt 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.

    PMID: 21695057RESULT

  • 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.

    PMID: 30249322RESULT

  • 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.

    PMID: 28374172RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Breast Milk

Study Officials

  • Gülhan SAMUR, Professor

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

August 27, 2019

First Posted

August 28, 2019

Study Start

May 5, 2018

Primary Completion

September 5, 2018

Study Completion

July 5, 2019

Last Updated

August 28, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)