HealthyNCT05738460
Effects of IAP-EOGBSD on Offspring's Gut Microbiome and Immunity.
An observational study of Healthy and Metabolism, run by Zhujiang Hospital at 1 site in China.
Trial summary
This study is planned to be recruited in two hospitals in South China, Zhujiang Hospital of Southern Medical University and Zhongshan Boai Hospital Recruit participants, plan to recruit obstetrics and child health departments in study hospitals, meet inclusion and discharge criteria 1~3 infants, a total of 360… Read more about this study
- Who is it for?
- Ages 37 to 41 weeks
- Conditions the study is for
- Healthy, Metabolism, Microbiome
- What is being tested?
- antibiotics
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 23 Feb 2022to 30 Jun 2023
- 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 37 to 41 weeks
- All sexes
- Child
Study population: Infants: 37-41 weeks of age, born through vaginal delivery, 2500g<= birth weight < 4000g, 0-3 years of age; 2. The mother: birth ranging in age from 18 to 40 years old, the single pregnancy, pregnancy 35 - 41 weeks to complete the GBS screening; 3. The guardian agrees to participate in the study voluntarily.
Who may be able to join
- Infants:37-41 weeks of age, born through vaginal delivery, 2500g<= birth weight < 4000g,0-3 years of age;
- The mother: birth ranging in age from 18 to 40 years old, the single pregnancy, pregnancy 35 -41 weeks to complete the GBS screening;
- The guardian agrees to participate in the study voluntarily.
Who cannot join
- Infants and children with serious congenital abnormalities, infections or clinical diseases;
- Antibiotics should be used in infants within 2 weeks, probiotics, prebiotics and biostime should be supplemented, or long-term drug treatment should be given for digestive, immune, blood and other diseases;
- Infant mothers: childbirth after long-term drug treatment due to digestive, immune, blood and chronic diseases during pregnancy; Or infants who were breastfed within 12 hours of antibiotic use after delivery;
- Any medical or non-medical condition that the investigator deems inappropriate to participate in.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Intrapartum Antibiotic Prophylaxis to Prevent Group B Streptococcal Early-onset Disease on Intestinal Microbiome and Immunity of Offspring
This study is planned to be recruited in two hospitals in South China, Zhujiang Hospital of Southern Medical University and Zhongshan Boai Hospital Recruit participants, plan to recruit obstetrics and child health departments in study hospitals, meet inclusion and discharge criteria 1~3 infants, a total of 360, recruited by Pearl River Hospital of Southern Medical University and Zhongshan Boai Hospital 180 people each.
Read the detailed description
This is a case-control study. By collecting fecal samples of infants and young children in the observation group and control group at different time points (0~1 years old, 1~2 years old, 2~3 years old), the intestinal flora of infants and young children was detected by 16S rDNA sequencing, and fecal calprotectin (CP) and secretory IgA (SIgA) were detected by ELISA. To study the effects of exposure factors on intestinal flora and immunity in offspring.
- Conditions
- Healthy, Metabolism, Microbiome
- Being tested
- antibiotics
- Keywords
- Microbiome,, maternal and offspring, healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antibioticsDrug
Also called antibiotic
Reproductive tract GBS colonization group of mothers during pregnancy，Use of antibiotics
| Study group | Role | What they receive |
|---|---|---|
| Reproductive tract GBS colonization group of mothers during pregnancy | Reproductive tract GBS colonization group of mothers during pregnancy，Use of antibiotics Receives: Drug: antibiotics | |
| No reproductive tract GBS colonization group in mothers during pregnancy | No reproductive tract GBS colonization group in mothers during pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal flora
Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the gut microbiome.
Measured: Fecal samples of infants and young children in the observation group and control group at different time points (0~1 years old) of offspring were collected
Secretory IgA
Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the secretory IgA of offspring.
Measured: Fecal samples of infants and young children in the observation group and control group at different time points (0~1 years old) of offspring were collected
Calprotectin
Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the cailprotectin of offspring.
Measured: Fecal samples of infants and young children in the observation group and control group at different time points (0~1 years old) of offspring were collected
Secondary outcomes (3)
Intestinal flora
Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the gut microbiome.
Measured: Fecal samples of infants and young children in the observation group and control group at different time points 1~2 years of offspring were collected
Secretory IgA
Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the secretory IgA of offspring.
Measured: Fecal samples of infants and young children in the observation group and control group at different time points 1~2 years of offspring were collected
Calprotectin
Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the cailprotectin of offspring.
Measured: Fecal samples of infants and young children in the observation group and control group at different time points 1~2 years of offspring were collected
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start23 Feb 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhongshan Bo Ai Hospital
- Responsible party
- Sponsor
- Investigators
- Qian Wang, Study chair, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05738460
- Sponsor's protocol ID
- CMOH2102
- Status last verified
- Feb 2022
- First submitted
- 18 Jan 2023
- Last updated
- 22 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Intrapartum Antibiotic Prophylaxis to Prevent Group B Streptococcal Early-onset Disease on Intestinal Microbiome and Immunity of Offspring
- ClinicalTrials.gov ID
- NCT05738460
- Acronym / sponsor ID
- CMOH2102
- Conditions
- Healthy, Metabolism, Microbiome
- Keywords
- Microbiome,, maternal and offspring, healthy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Collaborators
- Zhongshan Bo Ai Hospital
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 22 Feb 2023 (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.
This study is planned to be recruited in two hospitals in South China, Zhujiang Hospital of Southern Medical University and Zhongshan Boai Hospital Recruit participants, plan to recruit obstetrics and child health departments in study hospitals, meet inclusion and discharge criteria 1~3 infants, a total of 360, recruited by Pearl River Hospital of Southern Medical University and Zhongshan Boai Hospital 180 people each.
Detailed description
This is a case-control study. By collecting fecal samples of infants and young children in the observation group and control group at different time points (0~1 years old, 1~2 years old, 2~3 years old), the intestinal flora of infants and young children was detected by 16S rDNA sequencing, and fecal calprotectin (CP) and secretory IgA (SIgA) were detected by ELISA. To study the effects of exposure factors on intestinal flora and immunity in offspring.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reproductive tract GBS colonization group of mothers during pregnancy | – | Drug: antibioticsReproductive tract GBS colonization group of mothers during pregnancy，Use of antibiotics |
| No reproductive tract GBS colonization group in mothers during pregnancy | – | –No reproductive tract GBS colonization group in mothers during pregnancy |
Who may qualify
- Ages
- 37 to 41 weeks
- Sex
- All
- Age groups
- Child
- Study population
- Infants: 37-41 weeks of age, born through vaginal delivery, 2500g<= birth weight < 4000g, 0-3 years of age; 2. The mother: birth ranging in age from 18 to 40 years old, the single pregnancy, pregnancy 35 - 41 weeks to complete the GBS screening; 3. The guardian agrees to participate in the study voluntarily.
Key inclusion criteria (3 listed)
- Infants:37-41 weeks of age, born through vaginal delivery, 2500g<= birth weight < 4000g,0-3 years of age;
- The mother: birth ranging in age from 18 to 40 years old, the single pregnancy, pregnancy 35 -41 weeks to complete the GBS screening;
- The guardian agrees to participate in the study voluntarily.
Key exclusion criteria (4 listed)
- Infants and children with serious congenital abnormalities, infections or clinical diseases;
- Antibiotics should be used in infants within 2 weeks, probiotics, prebiotics and biostime should be supplemented, or long-term drug treatment should be given for digestive, immune, blood and other diseases;
- Infant mothers: childbirth after long-term drug treatment due to digestive, immune, blood and chronic diseases during pregnancy; Or infants who were breastfed within 12 hours of antibiotic use after delivery;
- Any medical or non-medical condition that the investigator deems inappropriate to participate in.
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 |
|---|---|---|
| antibioticsAlso: antibioticReproductive tract GBS colonization group of mothers during pregnancy，Use of antibiotics | Drug | Reproductive tract GBS colonization group of mothers during pregnancy |
Primary outcome
Intestinal flora
Time frame: Fecal samples of infants and young children in the observation group and control group at different time points (0~1 years old) of offspring were collected
Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the gut microbiome.
Secretory IgA
Time frame: Fecal samples of infants and young children in the observation group and control group at different time points (0~1 years old) of offspring were collected
Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the secretory IgA of offspring.
Calprotectin
Time frame: Fecal samples of infants and young children in the observation group and control group at different time points (0~1 years old) of offspring were collected
Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the cailprotectin of offspring.
3 secondary outcomes
Intestinal flora
Time frame: Fecal samples of infants and young children in the observation group and control group at different time points 1~2 years of offspring were collected
Secretory IgA
Time frame: Fecal samples of infants and young children in the observation group and control group at different time points 1~2 years of offspring were collected
Calprotectin
Time frame: Fecal samples of infants and young children in the observation group and control group at different time points 1~2 years of offspring were collected
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
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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.
Qian Wang study chair
Southern Medical University, China
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 Metabolism, 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 3 inclusion and 4 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 22 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intestinal flora (time frame: Fecal samples of infants and young children in the observation group and control group at different time points (0~1 years old) of offspring were collected). The study lists 3 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 22 Feb 2023.