Establishment of the Breast Milk Database in China

NCT ID: NCT03675204

Last Updated: 2019-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-19

Study Completion Date

2018-12-30

Brief Summary

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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

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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

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Breast Milk Collection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Heilongjiang Feihe Dairy Co. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shilong Jiang

Role: STUDY_DIRECTOR

Heilongjiang Feihe Dairy Co. Ltd.

Other Identifiers

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16-SC-05-FC-001

Identifier Type: -

Identifier Source: org_study_id

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