Omics Sequencing of Specimen Derived From Mother-Infant-Pairs
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 40
SponsorZhujiang Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
healthy pregnant women aged between 20y and 40y.
Vaginal birth
BMI<23.5 before pregnancy
Infants' birth weight, between 2500g and 4000g.
Disqualifiers
gestational diabetes
diagnosis of depressive disorder during pregnancy
gestational hypertension
diagnosis of other diseases during pregnancy
Trial 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
Trial design
Design model
Family-based
Time perspective
Prospective
Treatments tested in this trial
Sample collection
Other interventionCollect breast-milk and feces from mother-infant-pairs.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Mother1 intervention
Group B: Infant1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
2021.7.1-2026.12.302
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.
Time frame
2021.7.1-2026.12.30Secondary 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.
Time frame
2021.7.1-2026.12.30Sponsors and contacts
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Source ClinicalTrials.gov