- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04277260
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
Study Overview
Status
Conditions
Detailed Description
Objective:
- Analyze and compare the differences in HMOs components among mothers who give birth at different gestational weeks;
- Longitudinal observation of weekly changes in HMOs concentrations of premature mothers within 1 month of delivery;
- Validate the association between HMOs components in preterm mothers and fecal intestinal flora in infants at 6 months of age.
Research content
- 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;
- 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;
- Use statistical methods to verify the association between HMOs components in preterm mothers and the establishment of intestinal flora in infants.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Shanghai, China
- Recruiting
- Shanghai first maternal and infant health care hospital
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Contact:
- Jing Li
- Phone Number: +86 13585683669
- Email: zzhlq3@hotmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Human milk oligosaccharide detection
Time Frame: Day7-12, Day14-19, Day21-26, Day28-33
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To dectect the intestinal flora with16s RNA high throughput sequencing
Time Frame: Day7-12, Day28-33, 3 months and 6 months
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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
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Achieved the body weight of infants
Time Frame: Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months.
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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.
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Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months.
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Achieved the body length of infants
Time Frame: Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months.
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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.
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Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months.
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Achieved the head circumference of infants
Time Frame: Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months.
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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.
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Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months.
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Stool status of infants
Time Frame: Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months.
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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.
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Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months.
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Average daily formula intake
Time Frame: Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months.
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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.
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Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months.
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Disease and medication history
Time Frame: 6 months
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Record the disease and medication history of infants in each group
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6 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Jing Li, PhD, Shanghai Children's Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SCMCIRB-K2019023-2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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