Molecular Structure and Content of Human Milk Oligosaccharides (HMOs) and Its Effect on Infant Health in China
NCT ID: NCT04277260
Last Updated: 2020-02-20
Study Results
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Basic Information
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UNKNOWN
120 participants
OBSERVATIONAL
2019-04-08
2022-04-30
Brief Summary
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Detailed Description
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1. Analyze and compare the differences in HMOs components among mothers who give birth at different gestational weeks;
2. Longitudinal observation of weekly changes in HMOs concentrations of premature mothers within 1 month of delivery;
3. Validate the association between HMOs components in preterm mothers and fecal intestinal flora in infants at 6 months of age.
Research content
1. The LC-MS method will be used to detect the content of HMOs in preterm mothers and compared with the corresponding components in term breast milk during the postpartum period to analyze the effects of different gestational weeks on HMOs;
2. The intestinal flora 16S rDNA high-throughput sequencing method will be used to determine the bacterial gene profile in the fecal DNA samples of infants, and the differences between the gestational age groups (term and preterm infants) were compared, and the preterm infants in this group were plotted Evolution of intestinal flora within 6 months of birth;
3. Use statistical methods to verify the association between HMOs components in preterm mothers and the establishment of intestinal flora in infants.
Conditions
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Study Design
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CASE_CONTROL
OTHER
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* (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
Exclusion Criteria
* (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
7 Days
35 Years
ALL
No
Sponsors
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Heilongjiang Feihe Dairy Co. Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Jing Li, PhD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Children's Medical Center
Locations
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Shanghai first maternal and infant health care hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SCMCIRB-K2019023-2
Identifier Type: -
Identifier Source: org_study_id
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