Clinical trial NCT04277260: Molecular Structure and Content of Human Milk Oligosaccharides (HMOs) and Its Effect on Infant Health in China
Official title: Study on the Molecular Structure and Content of Human Milk Oligosaccharides (HMOs) in Breast Milk and Its Effect on Infant Health in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Child Development
Lead sponsor: Heilongjiang Feihe Dairy Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2020-02-20
Enrollment: 120
Sex: ALL
Minimum age (years): 7
Maximum age (years): 35
Standard ages: CHILD
ADULT
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lactating mothers and infants in cooperative maternity hospital

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Human milk oligosaccharide detection
timeFrame: Day7-12, Day14-19, Day21-26, Day28-33
Secondary outcomes:
measure: To dectect the intestinal flora with16s RNA high throughput sequencing
timeFrame: Day7-12, Day28-33, 3 months and 6 months
measure: Achieved the body weight of infants
timeFrame: Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months.
measure: Achieved the body length of infants
timeFrame: Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months.
measure: Achieved the head circumference of infants
timeFrame: Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months.
measure: Stool status of infants
timeFrame: Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months.
measure: Average daily formula intake
timeFrame: Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months.
measure: Disease and medication history
timeFrame: 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai first maternal and infant health care hospital
Study officials:
affiliation: Shanghai Children's Medical Center
name: Jing Li, PhD
role: PRINCIPAL_INVESTIGATOR
References: