Molecular Structure and Content of Human Milk Oligosaccharides (HMOs) and Its Effect on Infant Health in China
Study on the Molecular Structure and Content of Human Milk Oligosaccharides (HMOs) in Breast Milk and Its Effect on Infant Health in China
1 other identifier
observational
120
1 country
1
Brief Summary
In the study, the composition and content of human milk oligosaccharides in premature delivery mothers in China will be examined to investigate the differences in oligosaccharide concentrations in preterm breast milk from different gestational weeks. This study will fill a gap in human milk research in China, provide theoretical basis for the superiority of breastfeeding, and provide more powerful nutritional support for the catch-up growth of preterm infants
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 8, 2019
CompletedFirst Submitted
Initial submission to the registry
February 13, 2020
CompletedFirst Posted
Study publicly available on registry
February 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedFebruary 20, 2020
February 1, 2020
2.5 years
February 13, 2020
February 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Human milk oligosaccharide detection
Liquid chromatography-mass spectrometer(LC-MS) will be used to quantitatively detect a total of 15 types of neutral oligosaccharides and acid oligosaccharides in different breast milk samples. Human milk samples will be collected four times for each mother after delivery (day7-12, day14-19, day21-26, day28-33). Only one series of samples will be collected for each mother, and 30 samples are needed for each group, totaling 480 human milk samples
Day7-12, Day14-19, Day21-26, Day28-33
Secondary Outcomes (7)
To dectect the intestinal flora with16s RNA high throughput sequencing
Day7-12, Day28-33, 3 months and 6 months
Achieved the body weight of infants
Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months.
Achieved the body length of infants
Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months.
Achieved the head circumference of infants
Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months.
Stool status of infants
Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months.
- +2 more secondary outcomes
Study Arms (4)
Full term delivery
In the cooperative obstetric hospital, 30 cases of full-term delivery healthy mothers and their infants are selected. Each pair of nursing mothers and infants will complete the observation for 6 months. The samples of human milk and newborn feces are the experimental objects.
Preterm delivery(35-37 weeks)
In the cooperative obstetric hospital, 30 cases of preterm delivery(35-37 weeks) mothers and their infants are selected. Each pair of nursing mothers and infants will complete the observation for 6 months. The samples of human milk and newborn feces are the experimental objects.
Preterm delivery(32-35 weeks)
In the cooperative obstetric hospital, 30 cases of preterm delivery(32-35 weeks) mothers and their infants are selected. Each pair of nursing mothers and infants will complete the observation for 6 months. The samples of human milk and newborn feces are the experimental objects.
Preterm delivery(28-32 weeks)
In the cooperative obstetric hospital, 30 cases of preterm delivery(28-32 weeks) mothers and their infants are selected. Each pair of nursing mothers and infants will complete the observation for 6 months. The samples of human milk and newborn feces are the experimental objects.
Eligibility Criteria
Lactating mothers and infants in cooperative maternity hospital
You may qualify if:
- (1) Be healthy, have no acute or chronic diseases, have no severe complications during pregnancy
- (2) Breastfeeding for more than 6 months and Volunteer to participate in this study (signed informed consent)
- (3) Age of maternal women: 20\~35years
- (4) Breast milk is sufficient, and the amount of milk secreted each time is more than 30ml
- (5) No fatal, important organ system deformities and metabolic defects in neonates
You may not qualify if:
- (1) for infants: Rescued to death or hospitalized due to critical illness during the study period
- (2)for lactating mothers: exposure to tobacco and alcohol during lactation, severe postpartum depression and other mental and psychological diseases, obesity (BMI\> 28), use of antibiotics or antimetabolites, mastitis with fever within 7 days before specimen collection (T\> 38.5 ℃),Suspension or termination of breastfeeding in the state of maternal and infant illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai first maternal and infant health care hospital
Shanghai, China
Biospecimen
Fecal specimen of infants
Study Officials
- PRINCIPAL INVESTIGATOR
Jing Li, PhD
Shanghai Children's Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2020
First Posted
February 20, 2020
Study Start
April 8, 2019
Primary Completion
October 1, 2021
Study Completion
April 1, 2022
Last Updated
February 20, 2020
Record last verified: 2020-02