Probiotics Capsule as Supplemental Therapy for Group B Streptococci Infection and Vaginitis During Pregnancy

April 26, 2015 updated by: Meng-Hsing Wu

A Double-blind,Randomized,Parallel,Placebo-controlled Study of Probiotics Capsule as Supplemental Therapy for Group B Streptococci Infection and Vaginitis During Pregnancy

B streptococcal infection and the major cause of death before and after the baby is born. B streptococcus infection the way of the newborn, usually infection from the mother in childbirth, if the pregnant women during pregnancy early diagnosis B streptococcus infection, it can be effective in preventing the risk of neonatal infection. Department of Health in China has been since April 15, 2012, the Scholarship holder at all pregnant women in the 35-37 weeks of pregnancy comprehensive B streptococcus screening. Infection B Streptococcus pregnant women in the labor process, the use of prophylactic antibiotics can be effective in reducing neonatal B streptococcus infection, but the possibility of the fetus being infected for the condition of premature birth or early rupture of membranes are still unable to fully hedge. In this study, the 35 to 37 weeks gestation examination confirmed infected B Streptococcus pregnant women, oral lactobacillus capsules B streptococcus infection treatment efficacy and safety assessment of clinical research. To assess whether oral administration of lactic acid bacteria will affect vaginitis incidence.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Deeply influenced of bacterial vaginosis infection during pregnancy for pregnant women and fetus during childbirth, in which Group B Streptococcus agalactiae(GBS) is generally about 30% of pregnant women will be infected, about 1% vertical and infect the fetus, babies are not infected about 50% of the mortality rate in the treatment status, is considered an important reason for infection and death before and after the baby is born. Vertically in the natural childbirth process and infect the fetus, the delay in treatment on the fetus often lead to serious complications, including sepsis, pneumonia and meningitis, a serious will to cause death and permanent neurological sequelae, if given to confirm the diagnosis antibiotic treatment of pregnant women, the probability of infection of the newborn B streptococcus can be reduced by 75%. U.S. Centers for Disease Control recommends that pregnant women 35 to 37 weeks gestation or less than 37 weeks preterm contractions or rupture of membranes. B streptococcus check preterm doubts should pregnant women in the labor process and the use of preventive antibiotics can be effective in reducing neonatal B streptococcus infection, but the condition of premature birth or early rupture of membranes can not fully prevent the possibility of the fetus being infected is still in pre-production will not make any disposal, can cause infection of B The streptococci pregnant women worry, and under great pressure. This study for 35 to 37 weeks gestation to check to confirm infection of B Streptococcus pregnant women, pregnant women infected with the clinical studies of treatment efficacy and safety assessment of B streptococcus before delivery to the oral administration of lactic acid bacteria. The trial is expected during the execution in June 2012 to July 2015, subjects the number is expected to included at least 120 pregnant women choose not to subjects according to the conventional injection of prophylactic antibiotics in the labor process, choose to take oral lactobacillus oral lactobacillus of pregnant women in accordance with the 1:1 double-blind randomized to three groups, one of the following: test group A: oral lactobacillus capsules (dose of 2 x 109 cfu / capsule), experimental group B: oral without functional lactobacillus capsules and the control group: oral administration does not contain the active ingredient (lactic acid bacteria and cranberry) capsules before oral administration of lactic acid bacteria and the delivery process, collecting samples of vaginal anal secretions, whether positive addition to the screening B streptococcus, and the other selective medium coated plate culture for vaginal odor, itching number of the pathogen and B Streptococcus quantitative analysis and assessment questionnaire.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
      • Tainan, Taiwan
        • Recruiting
        • Department of Obstetrics and Gynecology, College of Medicine, National Cheng Kung University
        • Contact:
        • Principal Investigator:
          • Meng-Hsing Wu, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • pregnancy women at 35 weeks of gestation

Exclusion Criteria:

  • previous other probiotics capsules use
  • previous antibiotics use
  • previous habitual vaginal douche
  • previous medical disease, such as: HIV infection, cancer, history of organ transplantation, long-term steroid use, autoimmune disease, et al

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: latic acid bacteria and cranberry
oral latic acid bacteria and cranberry capsule (dose of 2 * 10^9 cfu per capsule), one pill daily
Dietary supplement: lactic acid bacteria
oral lactobacillus capsule (dose of 2 * 10^9 cfu per capsule), one pill daily
Dietary supplement: cranberry
oral cranberry capsule, one pill daily
Active Comparator: cranberry
oral cranberry capsule without lactic acid bacteria, one pill daily
Dietary supplement: cranberry
oral cranberry capsule, one pill daily
Placebo Comparator: placebo
placebo without lactic acid bacteria and cranberry, one pill daily
Dietary supplement: placebo
placebo capsule without lactic acid bacteria and cranberry, one pill daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
all cases vaginal group B streptococcus colonies
Time Frame: four years
four years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Meng-Hsing Wu

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cheng-Kung University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Meng-Hsing Wu, M.D., Ph.D., National Cheng Kung University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A-BR-101-065

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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