Child DevelopmentNCT04277260
Molecular Structure and Content of Human Milk Oligosaccharides (HMOs) and Its Effect on Infant Health in China
An observational study of Child Development, run by Heilongjiang Feihe Dairy Co. Ltd. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 7 days to 35 years
- Conditions the study is for
- Child Development
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 8 Apr 2019to Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 days to 35 years
- All sexes
- Child, Adult
Study population: Lactating mothers and infants in cooperative maternity hospital
Who may be able to join
- (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
Who cannot join
- (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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai first maternal and infant health care hospital
Shanghai
Jing Li, +86 13585683669, zzhlq3@hotmail.com
About this study
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
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
Read the 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.
- Conditions
- Child Development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day7-12, Day14-19, Day21-26, Day28-33
Secondary outcomes (7)
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.
Measured: Day7-12, Day28-33, 3 months and 6 months
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.
Measured: Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months.
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.
Measured: Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months.
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.
Measured: Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months.
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.
Measured: Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months.
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.
Measured: Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months.
Disease and medication history
Record the disease and medication history of infants in each group
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start8 Apr 2019
- Primary completionOct 2021 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heilongjiang Feihe Dairy Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jing Li, PhD, Principal investigator, Shanghai Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277260
- Sponsor's protocol ID
- SCMCIRB-K2019023-2
- Status last verified
- Feb 2020
- First submitted
- 13 Feb 2020
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04277260
- Acronym / sponsor ID
- SCMCIRB-K2019023-2
- Conditions
- Child Development
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Heilongjiang Feihe Dairy Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 20 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 7 days to 35 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Lactating mothers and infants in cooperative maternity hospital
Key inclusion criteria (5 listed)
- (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
Key exclusion criteria (2 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
7 secondary outcomes
To dectect the intestinal flora with16s RNA high throughput sequencing
Time frame: Day7-12, Day28-33, 3 months and 6 months
Achieved the body weight of infants
Time frame: Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months.
Achieved the body length of infants
Time frame: Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months.
Achieved the head circumference of infants
Time frame: Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months.
Stool status of infants
Time frame: Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months.
Average daily formula intake
Time frame: Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months.
Disease and medication history
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Li, PhD principal investigator
Shanghai Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Development, run by Heilongjiang Feihe Dairy Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Zhang, PhD (+86 10 8457 4688, zhangwei1@feihe.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Human milk oligosaccharide detection (time frame: Day7-12, Day14-19, Day21-26, Day28-33). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.