Molecular Structure and Content of Human Milk Oligosaccharides (HMOs) and Its Effect on Infant Health in China

China Feihe

Status: Unknown

Conditions: Child Development

Study type: Observational

Funder types: Industry

Identifiers

NCT04277260

SCMCIRB-K2019023-2

Details and patient eligibility

About

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

Full description

Objective:

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 7 days to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• (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

Exclusion criteria

• (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

Trial design

120 participants in 4 patient groups

Full term delivery

Description:

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)

Description:

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)

Description:

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)

Description:

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.