HealthyNCT05462366
Omics Sequencing of Specimen Derived From Mother-Infant-Pairs
An observational study of Healthy and Breast-milk Collection, run by Zhujiang Hospital at 1 site in China.
Trial summary
The investigators aim to collect breast-milk and feces from the participants, and apply culture techniques as well as omics sequencing technology to probe into the microbial and metabolomic signature of the specimens. Read more about this study
- Who is it for?
- Ages Up to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Breast-milk Collection, Feces
- What is being tested?
- Sample collection
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 22 Jun 2021to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: This study intends to screen pregnant women in the Obstetrics and Gynecology Center of Zhujiang Hospital, Southern Medical University, and preliminarily recruit subjects that meet the inclusion criteria according to clinical diagnosis and auxiliary examination results. According to the specific conditions of vaginal delivery and post-birth newborns, the final inclusion of healthy pregnant women and newborns will be determined, and a total of 40-50 mother-infant-pairs will be recruited
Who may be able to join
- healthy pregnant women aged between 20y and 40y.
- Vaginal birth
- BMI<23.5 before pregnancy
- Infants' birth weight, between 2500g and 4000g.
Who cannot join
- gestational diabetes
- diagnosis of depressive disorder during pregnancy
- gestational hypertension
- diagnosis of other diseases during pregnancy
- Under probiotics or antibiotic treatment from 3 months prior to pregnancy till 3 months after delivery
- histrory of smoking and drinking alcohol
- history of diarrhea from 3 months prior to pregnancy till 3 months after delivery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital
Guangzhou, Guangdong
Ying Ma, Doctor, 13113361169, mayingwuzhuoyi@126.com
About this study
The investigators aim to collect breast-milk and feces from the participants, and apply culture techniques as well as omics sequencing technology to probe into the microbial and metabolomic signature of the specimens.
- Conditions
- Healthy, Breast-milk Collection, Feces
- Being tested
- Sample collection
- Medical subject headings
- Breast Milk Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sample collectionOther
Collect breast-milk and feces from mother-infant-pairs.
| Study group | Role | What they receive |
|---|---|---|
| Mother | healthy mothers Receives: Other: Sample collection | |
| Infant | healthy infants Receives: Other: Sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the omics differences of the specimens between the experimental and control groups
Apply 16S amplicon sequencing and shotgun sequencing technology to obtain microbial structure of the specimens. The differences of microbial structure will be compared between the experimental and control groups. Significance among multiple groups was tested using a one-way analysis of variance (ANOVA), followed by the least significant difference (LSD) post hoc test. Groups with different characters denoting a significant difference, while having the same character denotes p-value > 0.05 in LSD test.
Measured: 2021.7.1-2026.12.30
Compare the microbial feature differences of the specimens between the experimental and control groups
Apply traditional culture technologies to validate and obtain human source bacteria.The differences of frequencies of probiotics will be compared between the experimental and control groups. Depending on the distribution of the variables, either the Mann-Whitney test or the unpaired Student's t-test was employed for quantitative variables. The Kruskal-Wallis test for mean values was used to evaluate non-parametric comparisons between participants in all groups. Significance among multiple groups was tested using a one-way analysis of variance (ANOVA), followed by the least significant difference (LSD) post hoc test. Groups with different characters denoting a significant difference, while having the same character denotes p-value > 0.05 in LSD test.
Measured: 2021.7.1-2026.12.30
Secondary outcomes (1)
Compare the health status differences between the experimental and control groups
After a brief introduction to the survey, participants were asked to complete a questionnaire. The differences of health status will be compared between the experimental and control groups. Depending on the distribution of the variables, either the Mann-Whitney test or the unpaired Student's t-test was employed for quantitative variables. The Kruskal-Wallis test for mean values was used to evaluate non-parametric comparisons between participants in all groups.
Measured: 2021.7.1-2026.12.30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start22 Jun 2021
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ma Ying, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462366
- Sponsor's protocol ID
- ZhujiangHFCYXZX
- Status last verified
- Jul 2023
- First submitted
- 6 Jul 2022
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omics Sequencing of Specimen Derived From Mother-Infant-Pairs
- ClinicalTrials.gov ID
- NCT05462366
- Acronym / sponsor ID
- ZhujiangHFCYXZX
- Conditions
- Healthy, Breast-milk Collection, Feces
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 18 Jul 2022 (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.
The investigators aim to collect breast-milk and feces from the participants, and apply culture techniques as well as omics sequencing technology to probe into the microbial and metabolomic signature of the specimens.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mother | – | Other: Sample collectionhealthy mothers |
| Infant | – | Other: Sample collectionhealthy infants |
Who may qualify
- Ages
- Up to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- This study intends to screen pregnant women in the Obstetrics and Gynecology Center of Zhujiang Hospital, Southern Medical University, and preliminarily recruit subjects that meet the inclusion criteria according to clinical diagnosis and auxiliary examination results. According to the specific conditions of vaginal delivery and post-birth newborns, the final inclusion of healthy pregnant women and newborns will be determined, and a total of 40-50 mother-infant-pairs will be recruited
Key inclusion criteria (4 listed)
- healthy pregnant women aged between 20y and 40y.
- Vaginal birth
- BMI<23.5 before pregnancy
- Infants' birth weight, between 2500g and 4000g.
Key exclusion criteria (7 listed)
- gestational diabetes
- diagnosis of depressive disorder during pregnancy
- gestational hypertension
- diagnosis of other diseases during pregnancy
- Under probiotics or antibiotic treatment from 3 months prior to pregnancy till 3 months after delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sample collectionCollect breast-milk and feces from mother-infant-pairs. | Other | Infant, Mother |
Primary outcome
Compare the omics differences of the specimens between the experimental and control groups
Time frame: 2021.7.1-2026.12.30
Apply 16S amplicon sequencing and shotgun sequencing technology to obtain microbial structure of the specimens. The differences of microbial structure will be compared between the experimental and control groups. Significance among multiple groups was tested using a one-way analysis of variance (ANOVA), followed by the least significant difference (LSD) post hoc test. Groups with different characters denoting a significant difference, while having the same character denotes p-value > 0.05 in LSD test.
Compare the microbial feature differences of the specimens between the experimental and control groups
Time frame: 2021.7.1-2026.12.30
Apply traditional culture technologies to validate and obtain human source bacteria.The differences of frequencies of probiotics will be compared between the experimental and control groups. Depending on the distribution of the variables, either the Mann-Whitney test or the unpaired Student's t-test was employed for quantitative variables. The Kruskal-Wallis test for mean values was used to evaluate non-parametric comparisons between participants in all groups. Significance among multiple groups was tested using a one-way analysis of variance (ANOVA), followed by the least significant difference (LSD) post hoc test. Groups with different characters denoting a significant difference, while having the same character denotes p-value > 0.05 in LSD test.
1 secondary outcome
Compare the health status differences between the experimental and control groups
Time frame: 2021.7.1-2026.12.30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Individual participant dataSharing planned: Undecided
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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.
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 Healthy and Breast-milk Collection, run by Zhujiang Hospital 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 25 Jul 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Ma, Doctor (13113361169, mayingwuzhuoyi@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the omics differences of the specimens between the experimental and control groups (time frame: 2021.7.1-2026.12.30). The study lists 2 primary outcomes in all. 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 25 Jul 2023.