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

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ClinicalTrials.gov Identifier: NCT04277260
Recruitment Status : Recruiting
First Posted : February 20, 2020
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
Heilongjiang Feihe Dairy Co. Ltd.

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

Condition or disease
Child Development

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.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Other
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
Actual Study Start Date : April 8, 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : April 2022

Group/Cohort
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.
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.



Primary Outcome Measures :
  1. Human milk oligosaccharide detection [ Time Frame: Day7-12, Day14-19, Day21-26, Day28-33 ]

    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



Secondary Outcome Measures :
  1. To dectect the intestinal flora with16s RNA high throughput sequencing [ Time Frame: Day7-12, Day28-33, 3 months and 6 months ]

    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.


  2. Achieved the body weight of infants [ Time Frame: Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months. ]
    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.

  3. Achieved the body length of infants [ Time Frame: Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months. ]
    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.

  4. Achieved the head circumference of infants [ Time Frame: Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months. ]
    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.

  5. Stool status of infants [ Time Frame: Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months. ]
    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.

  6. Average daily formula intake [ Time Frame: Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months. ]
    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.

  7. Disease and medication history [ Time Frame: 6 months ]
    Record the disease and medication history of infants in each group


Biospecimen Retention:   Samples With DNA
Fecal specimen of infants


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Lactating mothers and infants in cooperative maternity hospital
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04277260


Contacts
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Contact: Wei Zhang, PhD +86 10 8457 4688 zhangwei1@feihe.com

Locations
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China
Shanghai first maternal and infant health care hospital Recruiting
Shanghai, China
Contact: Jing Li    +86 13585683669    zzhlq3@hotmail.com   
Sponsors and Collaborators
Heilongjiang Feihe Dairy Co. Ltd.
Investigators
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Principal Investigator: Jing Li, PhD Shanghai Children's Medical Center

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Responsible Party: Heilongjiang Feihe Dairy Co. Ltd.
ClinicalTrials.gov Identifier: NCT04277260    
Other Study ID Numbers: SCMCIRB-K2019023-2
First Posted: February 20, 2020    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No