Breast MilkMuRuNCT02070562
Human Milk Profiles and Dietary Intake of Chinese Lactating Mothers During Early Lactation Period in Shanghai
An observational study of Breast Milk, run by Dumex Baby Food Co., Ltd. at 1 site in China.
Trial summary
This study aims to investigate breast milk composition and dietary habits of Chinese lactating mothers. Further understanding of the composition of human milk will help to understand the nutritional needs of mothers and their infants in their early phase of life which eventually will help to support breastfeeding. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Milk
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Feb 2014to Jun 2016
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: General health lactating mothers
Who may be able to join
- Generally healthy mothers who give birth to a healthy term infant (37-42 weeks) whose birth weight is >10 and <90 percentiles gestational birth weight chart.
- Aged 20 - 40 years.
- Mothers who intend to exclusively breastfeed the infant for more than 6 weeks.
- Chinese ethnicity, including both parents.
- Mothers who sign the informed consent form in writing.
Who cannot join
- Mothers:
- Participation in any other studies involving investigational or marketed products concomitantly or two weeks prior to entry into the study.
- Difficult to follow up and/or locate (e.g. known transfer to other hospitals, residing outside Shanghai, plan to move out of Shanghai).
- Current smoker or having smoked during the pregnancy.
- Having consumed alcoholic drinks during pregnancy or lactation.
- Illegal drug abuser: cannabinoids (marijuana, hashish), stimulants (cocaine, amphetamine, methamphetamine), opioid (heroin, opium).
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- Acute infection disease or neoplastic disease or any kind of weakening or debilitating conditions (no history of positive HBV, HCV or HIV serological test at any time during the pregnancy).
- Use of drug or pharmacologically active substances (e.g. herbal products, traditional medicine) to treat a particular disease or medical condition from the beginning of lactation ( those who consume herbal/traditional medicine for maintaining or improving well-being will still be included).
- Presence of mastitis, fungal infections of the nipple or areola; reactivation of herpes simplex (HSV) or varicella zoster infection in the mammary or thoracic region at the time of enrolment.
- Presence of endocrinology diseases, particularly diabetes mellitus and gestational diabetes.
- Presence of obesity (pre-pregnancy BMI > 28).
- Presence of chronic diseases such as cardiovascular, renal, respiratory and hepatic diseases.
- Presence of psychosis and severe post-partum depression.
- Presence of autoimmune disease such as systemic lupus erythematosus, systemic scleroderma, ulcerative colitis, Crohn's disease, celiac disease.
- Women whose health condition, according to the investigator's judgement, could interfere with the study conduct and assessment.
- Mothers who have given birth to twins or multiples or infant conceived with Assisted Reproductive Technology (ART).
- Elimination diet due to chronic allergic diseases or vegan.
- Incapability of subject to comply with study protocol or investigator's uncertainty about the willingness or ability of the mothers to understand and comply with the protocol requirements.
- Infants:
- Any congenital abnormality, chromosomal disorder or severe disease which could interfere with the study conduct and assessment.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to investigate breast milk composition and dietary habits of Chinese lactating mothers. Further understanding of the composition of human milk will help to understand the nutritional needs of mothers and their infants in their early phase of life which eventually will help to support breastfeeding.
- Conditions
- Breast Milk
- Keywords
- breast milk, dietary survey
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 |
|---|---|---|
| Community Group | Chinese lactating mothers from community maternal \& child healthcare centre | |
| VIP Group | Chinese lactating mothers from VIP clinics (maternal care center) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast milk composition
Human milk oligosaccharides profiles, fatty acids profile, macronutrients and energy content will be measured.
Measured: 0-42 day postpartum
Secondary outcomes (3)
Growth
Infant's anthropometrics (weight, length, head circumference).
Measured: 0-42 day postpartum
Maternal diet survey
Dietary macronutrients and energy intake, and food patterns will be assessed.
Measured: 0-42 day postpartum
Infection
Parent-reported infection patterns of infants during the observation period.
Measured: 0-42 day postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2015 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast MilkStudies 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dumex Baby Food Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Children's Medical Center
- Responsible party
- Sponsor
- Investigators
- Jing Li, professor, Principal investigator, Shanghai Children's Medical Center Affiliated Shanghai Jiao Tong University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070562
- Sponsor's protocol ID
- HMR.1.C/A
- Acronym
- MuRu
- Status last verified
- Feb 2015
- First submitted
- 27 Jan 2014
- Last updated
- 9 Feb 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Milk Profiles and Dietary Intake of Chinese Lactating Mothers During Early Lactation Period in Shanghai
- ClinicalTrials.gov ID
- NCT02070562
- Acronym / sponsor ID
- MuRu / HMR.1.C/A
- Conditions
- Breast Milk
- Keywords
- breast milk, dietary survey
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Dumex Baby Food Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Children's Medical Center
- Study start
- Feb 2014
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 25 Feb 2014 (estimated)
- 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.
This study aims to investigate breast milk composition and dietary habits of Chinese lactating mothers. Further understanding of the composition of human milk will help to understand the nutritional needs of mothers and their infants in their early phase of life which eventually will help to support breastfeeding.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community Group | – | –Chinese lactating mothers from community maternal \& child healthcare centre |
| VIP Group | – | –Chinese lactating mothers from VIP clinics (maternal care center) |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- General health lactating mothers
Key inclusion criteria (5 listed)
- Generally healthy mothers who give birth to a healthy term infant (37-42 weeks) whose birth weight is >10 and <90 percentiles gestational birth weight chart.
- Aged 20 - 40 years.
- Mothers who intend to exclusively breastfeed the infant for more than 6 weeks.
- Chinese ethnicity, including both parents.
- Mothers who sign the informed consent form in writing.
Key exclusion criteria (20 listed)
- Participation in any other studies involving investigational or marketed products concomitantly or two weeks prior to entry into the study.
- Difficult to follow up and/or locate (e.g. known transfer to other hospitals, residing outside Shanghai, plan to move out of Shanghai).
- Current smoker or having smoked during the pregnancy.
- Having consumed alcoholic drinks during pregnancy or lactation.
- Illegal drug abuser: cannabinoids (marijuana, hashish), stimulants (cocaine, amphetamine, methamphetamine), opioid (heroin, opium).
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
Breast milk composition
Time frame: 0-42 day postpartum
Human milk oligosaccharides profiles, fatty acids profile, macronutrients and energy content will be measured.
3 secondary outcomes
Growth
Time frame: 0-42 day postpartum
Maternal diet survey
Time frame: 0-42 day postpartum
Infection
Time frame: 0-42 day postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2015.
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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.
Jing Li, professor principal investigator
Shanghai Children's Medical Center Affiliated Shanghai Jiao Tong University, School of Medicine
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, run by Dumex Baby Food Co., Ltd. at 1 site in China.
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 20 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 9 Feb 2015. 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 China. 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?
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?
Breast milk composition (time frame: 0-42 day postpartum). 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 9 Feb 2015.