Establishment of the Breast Milk Database in China

Breast Milk Collection Clinical Trial

Official title:

Establishment of the Breast Milk Database in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03675204
• Other study ID #: 16-SC-05-FC-001
• Status: Completed
• Start date: October 19, 2016
• Est. completion date: December 30, 2018

Study information

• Verified date: September 2018
• Source: Heilongjiang Feihe Dairy Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1800
• Est. completion date: December 30, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 35 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Breast Milk Collection

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Heilongjiang Feihe Dairy Co. Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Protein in breast milk	Protein in breast milk measured in percent (%)	At enrollment
Secondary	Osmotic pressure	Osmotic pressure (mmolOsm/Lkg.H2O) in breast milk	At enrollment
Secondary	Fatty acids in breast milk	Fatty acids composition (mg/L) in breast milk	At enrollment
Secondary	Amino acids	Amino acids composition (mg/L) in breast milk	At enrollment
Secondary	Oligosaccharides	Oligosaccharides levels (mg/L) in breast milk	At enrollment
Secondary	Probiotics	Probiotics composition (species) measured using gene sequencing in breast milk;	At enrollment
Secondary	Vitamins	Vitamins composition (µg/L) in breast milk	At enrollment
Secondary	Minerals	Minerals composition (mg/L) in breast milk	At enrollment
Secondary	Hormones	Hormones composition (mg/L) in breast milk	At enrollment
Secondary	Dietary composition of participating mothers	Investigation on the dietary composition of participating mothers obtained using questionnaire	At enrollment
Secondary	Height of participating mothers	Height measurement (cm) of participating mothers	At enrollment
Secondary	Weight of participating mothers	Body weight measurement (kg) of participating mothers	At enrollment
Secondary	Age of participating mothers	Age (years) of participating mothers obtained using questionnaire	At enrollment
Secondary	Educational level of participating mothers	Educational level of participating mothers obtained using questionnaire	At enrollment
Secondary	Occupation of participating mothers	Occupation of participating mothers obtained using questionnaire	At enrollment
Secondary	Physical health condition of participating mothers	Physical health condition of participating mothers assessed by questionnaire	At enrollment
Secondary	Triglyceride	Triglyceride (mg/g) contents in breast milk	At enrollment
Secondary	Phospholipid	Phospholipid (mg/g) contents in breast milk	At enrollment