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

Child Development Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04277260
• Other study ID #: SCMCIRB-K2019023-2
• Status: Recruiting
• Start date: April 8, 2019
• Est. completion date: April 2022

Study information

• Verified date: February 2020
• Source: Heilongjiang Feihe Dairy Co. Ltd.
• Contact: Wei Zhang, PhD
• Phone: +86 10 8457 4688
• Email: zhangwei1[@]feihe.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 2022
• Est. primary completion date: October 2021
• Gender: All
• Age group: N/A to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Development

Locations

Country	Name	City	State
China	Shanghai first maternal and infant health care hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Heilongjiang Feihe Dairy Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To dectect the intestinal flora with16s RNA high throughput sequencing	The results of bacterial gene profiles in fecal DNA samples of premature infants at different gestational ages will be analyzed as follows.First, bacterial genomic DNA in feces will be obtained using the QIAamp Fast DNA Stool Mini Kit(51604), and PCR amplification will be performed. After the Miseq library are successfully constructed, cluster preparation and sequencing will be performed with qualified libraries. The data obtained by the machine will be used for biological information analysis. By comparing OTU with database, species annotation will be performed on OTU.Based on OTU and species annotation results, species complexity analysis and inter-group species difference analysis will be carried out.; Neonatal fecal samples will be collected four times for each infant after delivery at day7-12, day28-33, 3 months and 6 months of age. Only one series of samples will be collected from each infant, and 30 samples are needed for each group, totaling 480 fecal samples.	Day7-12, Day28-33, 3 months and 6 months
Secondary	Achieved the body weight of infants	Measured the body weight (grams) of infants at 8 time points: Day7-Day12, Day14-Day19, Day21-Day26, Day28-Day33, 2 months, 3 months, 4months and 6 months.	Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months.
Secondary	Achieved the body length of infants	Measured the body length (mm) of infants at 8 time points: Day7-Day12, Day14-Day19, Day21-Day26, Day28-Day33, 2 months, 3 months, 4months and 6 months.	Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months.
Secondary	Achieved the head circumference of infants	Measured the head circumference (mm) of infants at 8 time points: Day7-Day12, Day14-Day19, Day21-Day26, Day28-Day33, 2 months, 3 months, 4months and 6 months.	Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months.
Secondary	Stool status of infants	Achieved the stool status( frequency, color, character)of neonatal based on health consultation at 8 time points: Day7-Day12, Day14-Day19, Day21-Day26, Day28-Day33, 2 months, 3 months, 4months and 6 months.	Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months.
Secondary	Average daily formula intake	Achieved the average daily formula intake volume at 8 time points: Day7-Day12, Day14-Day19, Day21-Day26, Day28-Day33, 2 months, 3 months, 4months and 6 months.	Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months.
Secondary	Disease and medication history	Record the disease and medication history of infants in each group	6 months