NCT03675204

Brief Summary

Collect breast milk samples in various administrative regions of China to measure the nutrients in breast milk; analyze the composition of nutrients; and establish the database of breast milk in China.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Typical duration for all trials

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

October 19, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 5, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 18, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

July 31, 2019

Status Verified

September 1, 2018

Enrollment Period

1.8 years

First QC Date

September 5, 2018

Last Update Submit

July 29, 2019

Conditions

Breast Milk Collection

Outcome Measures

Primary Outcomes (1)

  • Protein in breast milk

    Protein in breast milk measured in percent (%)

    At enrollment

Secondary Outcomes (17)

  • Osmotic pressure

    At enrollment

  • Fatty acids in breast milk

    At enrollment

  • Amino acids

    At enrollment

  • Oligosaccharides

    At enrollment

  • Probiotics

    At enrollment

  • +12 more secondary outcomes

Interventions

No interventionOTHER

No intervention

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy lactating mother of 25 \~ 35 years old who are currently breast-feeding infants of 15 \~180 days old. Subjects are equally distributed in the postpartum time period of 15\~35 days, 36\~65 days, 66\~95 days, 96\~125 days, 126\~55 days and 156\~185 days

You may qualify if:

  • Lactating mother 25 \~ 35 years old;
  • Breast-feeding infants (15 \~180 days old );
  • Physically healthy by self-evaluation;
  • Does not smoke;
  • Does not drink alcohol;
  • Have given birth to physically healthy infants;
  • Signed the informed consent forms.

You may not qualify if:

  • Being treated for gastrointestinal symptoms;
  • Suffering from mastitis;
  • Suffering from infectious diseases (tuberculosis, viral hepatitis and HIV infection);
  • Suffering from cardiovascular disease;
  • Suffering from metabolic diseases (such as diabetes);
  • Suffering from mental system diseases;
  • Suffering from cancer and other malignant diseases;
  • Having history of taking antibiotics;
  • Not able to answer the study questions;
  • Participating in any nutritional or pharmaceutical intervention study recently.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

A minimum of 60ml of breast milk will be collected for each subject.

MeSH Terms

Conditions

Breast Milk Expression

Condition Hierarchy (Ancestors)

Breast FeedingFeeding BehaviorBehavior

Study Officials

  • Shilong Jiang

    Heilongjiang Feihe Dairy Co. Ltd.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2018

First Posted

September 18, 2018

Study Start

October 19, 2016

Primary Completion

August 1, 2018

Study Completion

December 30, 2018

Last Updated

July 31, 2019

Record last verified: 2018-09