Microbiome, HumanNCT05738473

Effects of IAP-EOGBSD on Maternal Vaginal Microbiome, Offspring's Gut Microbiome and Metabolites.

An observational study of Microbiome, Human, run by Zhujiang Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for: Microbiome, Human
What is being tested?: antibiotic
How many people: 492 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 18 to 40 years
Women only
Healthy volunteers accepted
Adult

Study population: 1. Pregnant women are 18 to 40 years; 2. 35 to 41 weeks of pregnancy

Who may be able to join

Pregnant women are 18 to 40 years;
35 to 41 weeks of pregnancy;
Singleton pregnancy;
Plan for vaginal delivery and postpartum care in the research hospital;
Pregnant women who volunteered to participate in the study.

Who cannot join

Have infectious diseases, serious infections and clinical diseases;
Use of antibiotics in the past 2 weeks;
Long-term use of drugs due to digestion, immunity, blood, chronic diseases;
Sexual behavior, vaginal douching and topical medication within 24 hours before sampling;
Any medical or non-medical condition that the investigator considers inappropriate to participate.

Trial locations and contacts

1 site in 1 country.

China1 site

Zhujiang Hospital
Guangzhou, Guangdong, 510280

Other trials in China

About this study

Official title: The Effects of Intrapartum Antibiotic Prophylaxis to Prevent Group B Streptococcal Early-onset Disease on Maternal Vaginal Microbiome, Intestinal Microbiome and Immunity of Offspring

In view of the current status of prevention and research on GBS disease in mothers and infants at home and abroad, this project intends to explore the characteristics of vaginal microbiota of GBS-colonized pregnant women in southern China, the impact of IAP prevention of GBS-EOD on vaginal flora, and the effect of IAP prevention of GBS-EOD on intestinal flora and immune production in offspring, so as to improve the ability to prevent and treat GBS-related diseases in mothers and infants and promote maternal and infant health.

Read the detailed description

This project intends to explore the characteristics of vaginal microbiota of GBS-colonized pregnant women in southern China, the impact of IAP prevention of GBS-EOD on vaginal flora, and the effect of IAP prevention of GBS-EOD on intestinal flora and immune production in offspring, so as to improve the ability to prevent and treat GBS-related diseases in mothers and infants and promote maternal and infant health.

Conditions: Microbiome, Human
Being tested: antibiotic
Keywords: Microbiome,, maternal and offspring, healthy, whole genome sequencing of GBS strain., GBS test by(Q-PCR)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

antibioticDrug
For pregnant women with GBS colonization, antibiotics are used to prevent infection

Study groups in NCT05738473
Study group	Role	What they receive
pregnant women colonized by Group B Streptococcus (GBS) and undergoing IAP		vaginal microbiome of pregnant women colonized by Group B Streptococcus (GBS)、Pregnant women undergoing IAP Receives: Drug: antibiotic
pregnant women does not colonized by Group B Streptococcus (GBS) and not undergoing IAP		Group B streptococcus (GBS) does not colonize the vaginal microbiome of pregnant women、Pregnant wome

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 of offspring.
Measured: The offspring are born on the 3rd day after birth
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: The offspring are born on the 3rd day after birth
Calprotectin
Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the cailprotectin of offspring.
Measured: The offspring are born on the 3rd day after birth
Intestinal flora
Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the gut microbiome of offspring.
Measured: The offspring are born on the 42nd day after birth
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: The offspring are born on the 42nd day after birth
Calprotectin
Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the cailprotectin of offspring.
Measured: The offspring are born on the 42nd day after birth

Secondary outcomes (4)

The effect of IAP to prevent GBS-EOD.
Analyze the effect of IAP (intrapartum antibiotics prophylaxis) to prevent GBS-EOD on maternal vaginal microbiome.
Measured: Vaginal flora on days 3rd after delivery.
The characteristics of vaginal microbiome of pregnant women.
Analyze the characteristics of vaginal microbiome of pregnant women colonized by Group B Streptococcus (GBS).
Measured: Vaginal flora on days 3rd after delivery.
The effect of IAP to prevent GBS-EOD.
Analyze the effect of IAP (intrapartum antibiotics prophylaxis) to prevent GBS-EOD on maternal vaginal microbiome.
Measured: Vaginal flora on days 42nd after delivery.
The characteristics of vaginal microbiome of pregnant women.
Analyze the characteristics of vaginal microbiome of pregnant women colonized by Group B Streptococcus (GBS).
Measured: Vaginal flora on days 42nd after delivery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Feb 202230 Jun 2023

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 Microbiome, HumanStudies 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: 492 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05738473
Sponsor's protocol ID: CMOH2101
Status last verified: Jan 2023
First submitted: 18 Jan 2023
Last updated: 22 Feb 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Microbiome, Human trials

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 Maternal Vaginal Microbiome, Intestinal Microbiome and Immunity of Offspring
ClinicalTrials.gov ID: NCT05738473
Acronym / sponsor ID: CMOH2101
Conditions: Microbiome, Human
Keywords: Microbiome,, maternal and offspring, healthy, whole genome sequencing of GBS strain., GBS test by(Q-PCR)
Study type: Observational
Recruitment status: Unknown status
Enrolment: 492 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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
pregnant women colonized by Group B Streptococcus (GBS) and undergoing IAP	–	Drug: antibioticvaginal microbiome of pregnant women colonized by Group B Streptococcus (GBS)、Pregnant women undergoing IAP
pregnant women does not colonized by Group B Streptococcus (GBS) and not undergoing IAP	–	–Group B streptococcus (GBS) does not colonize the vaginal microbiome of pregnant women、Pregnant wome

Who may qualify

Ages: 18 to 40 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult
Study population: 1. Pregnant women are 18 to 40 years; 2. 35 to 41 weeks of pregnancy

Key inclusion criteria (5 listed)

Pregnant women are 18 to 40 years;
35 to 41 weeks of pregnancy;
Singleton pregnancy;
Plan for vaginal delivery and postpartum care in the research hospital;
Pregnant women who volunteered to participate in the study.

Key exclusion criteria (5 listed)

Have infectious diseases, serious infections and clinical diseases;
Use of antibiotics in the past 2 weeks;
Long-term use of drugs due to digestion, immunity, blood, chronic diseases;
Sexual behavior, vaginal douching and topical medication within 24 hours before sampling;
Any medical or non-medical condition that the investigator considers inappropriate to participate.

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
antibioticFor pregnant women with GBS colonization, antibiotics are used to prevent infection	Drug	pregnant women colonized by Group B Streptococcus (GBS) and undergoing IAP

Primary outcome

Intestinal flora
Time frame: The offspring are born on the 3rd day after birth
Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the gut microbiome of offspring.
Secretory IgA
Time frame: The offspring are born on the 3rd day after birth
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: The offspring are born on the 3rd day after birth
Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the cailprotectin of offspring.
Intestinal flora
Time frame: The offspring are born on the 42nd day after birth
Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the gut microbiome of offspring.
Secretory IgA
Time frame: The offspring are born on the 42nd day after birth
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: The offspring are born on the 42nd day after birth
Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the cailprotectin of offspring.

4 secondary outcomes

The effect of IAP to prevent GBS-EOD.
Time frame: Vaginal flora on days 3rd after delivery.
The characteristics of vaginal microbiome of pregnant women.
Time frame: Vaginal flora on days 3rd after delivery.
The effect of IAP to prevent GBS-EOD.
Time frame: Vaginal flora on days 42nd after delivery.
The characteristics of vaginal microbiome of pregnant women.
Time frame: Vaginal flora on days 42nd after delivery.

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.

Related trials for Microbiome, Human

Active, not recruitingObservational study
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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 Microbiome, Human, 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 5 inclusion and 5 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: The offspring are born on the 3rd day after birth). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05738473.

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.