Breast Milk CollectionNCT03675204
Establishment of the Breast Milk Database in China
An observational study of Breast Milk Collection, run by Heilongjiang Feihe Dairy Co. Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Milk Collection
- How many people
- 1,800 participants
- Where
- No sites listed yet
- Study dates
- 19 Oct 2016to 30 Dec 2018
- 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 25 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
About this study
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.
Read the detailed description
The study cities are Guangzhou, Weihai, Chengdu, Beijing, Harbin, Wuhan, Jinhua, Zhengzhou and Lanzhou.
Breast milk will be collected at 9:00-11:00 in the morning from 15 to180 days after giving birth. The nutrients (protein, triglyceride, phospholipid, oligosaccharides and probiotics) in the collected breast milk samples will be measured. These data will be used to establish the breast milk database in China. This databased will provide references for infant nutrient intake and for the formulation and revision of infant formula standards. It will also provide references for the development of new infant formula products in China.
- Conditions
- Breast Milk Collection
- Being tested
- No intervention
- Medical subject headings
- Breast Milk Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein in breast milk
Protein in breast milk measured in percent (%)
Measured: At enrollment
Secondary outcomes (17)
Osmotic pressure
Osmotic pressure (mmolOsm/Lkg.H2O) in breast milk
Measured: At enrollment
Fatty acids in breast milk
Fatty acids composition (mg/L) in breast milk
Measured: At enrollment
Amino acids
Amino acids composition (mg/L) in breast milk
Measured: At enrollment
Oligosaccharides
Oligosaccharides levels (mg/L) in breast milk
Measured: At enrollment
Probiotics
Probiotics composition (species) measured using gene sequencing in breast milk;
Measured: At enrollment
Vitamins
Vitamins composition (μg/L) in breast milk
Measured: At enrollment
Minerals
Minerals composition (mg/L) in breast milk
Measured: At enrollment
Hormones
Hormones composition (mg/L) in breast milk
Measured: At enrollment
Dietary composition of participating mothers
Investigation on the dietary composition of participating mothers obtained using questionnaire
Measured: At enrollment
Height of participating mothers
Height measurement (cm) of participating mothers
Measured: At enrollment
Weight of participating mothers
Body weight measurement (kg) of participating mothers
Measured: At enrollment
Age of participating mothers
Age (years) of participating mothers obtained using questionnaire
Measured: At enrollment
Educational level of participating mothers
Educational level of participating mothers obtained using questionnaire
Measured: At enrollment
Occupation of participating mothers
Occupation of participating mothers obtained using questionnaire
Measured: At enrollment
Physical health condition of participating mothers
Physical health condition of participating mothers assessed by questionnaire
Measured: At enrollment
Triglyceride
Triglyceride (mg/g) contents in breast milk
Measured: At enrollment
Phospholipid
Phospholipid (mg/g) contents in breast milk
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start19 Oct 2016
- Primary completion1 Aug 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Enrolment
- 1,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heilongjiang Feihe Dairy Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shilong Jiang, Study director, Heilongjiang Feihe Dairy Co. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675204
- Sponsor's protocol ID
- 16-SC-05-FC-001
- Status last verified
- Sep 2018
- First submitted
- 5 Sep 2018
- Last updated
- 31 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of the Breast Milk Database in China
- ClinicalTrials.gov ID
- NCT03675204
- Acronym / sponsor ID
- 16-SC-05-FC-001
- Conditions
- Breast Milk Collection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (actual)
- Lead sponsor
- Heilongjiang Feihe Dairy Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Oct 2016 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 18 Sep 2018 (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.
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.
Detailed description
The study cities are Guangzhou, Weihai, Chengdu, Beijing, Harbin, Wuhan, Jinhua, Zhengzhou and Lanzhou.
Breast milk will be collected at 9:00-11:00 in the morning from 15 to180 days after giving birth. The nutrients (protein, triglyceride, phospholipid, oligosaccharides and probiotics) in the collected breast milk samples will be measured. These data will be used to establish the breast milk database in China. This databased will provide references for infant nutrient intake and for the formulation and revision of infant formula standards. It will also provide references for the development of new infant formula products in China.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (10 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Protein in breast milk
Time frame: At enrollment
Protein in breast milk measured in percent (%)
17 secondary outcomes
Osmotic pressure
Time frame: At enrollment
Fatty acids in breast milk
Time frame: At enrollment
Amino acids
Time frame: At enrollment
Oligosaccharides
Time frame: At enrollment
Probiotics
Time frame: At enrollment
Vitamins
Time frame: At enrollment
Minerals
Time frame: At enrollment
Hormones
Time frame: At enrollment
Dietary composition of participating mothers
Time frame: At enrollment
Height of participating mothers
Time frame: At enrollment
Weight of participating mothers
Time frame: At enrollment
Age of participating mothers
Time frame: At enrollment
Educational level of participating mothers
Time frame: At enrollment
Occupation of participating mothers
Time frame: At enrollment
Physical health condition of participating mothers
Time frame: At enrollment
Triglyceride
Time frame: At enrollment
Phospholipid
Time frame: At enrollment
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 31 Jul 2019.
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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.
Shilong Jiang study director
Heilongjiang Feihe Dairy Co. Ltd.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Milk Collection, run by Heilongjiang Feihe Dairy Co. Ltd..
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 7 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: finished, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Protein in breast milk (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2019.