- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01779193
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
Unknown
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
200
Phase
- 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
- Name: Meng-Hsing Wu, M.D., Ph.D.
- Phone Number: 5222 +88662353535
- Email: mhwu68@mail.ncku.edu.tw
Study Locations
-
-
-
Tainan, Taiwan
- Recruiting
- Department of Obstetrics and Gynecology, College of Medicine, National Cheng Kung University
-
Contact:
- Meng-Hsing Wu, M.D., Ph.D.
- Phone Number: 5222 +88662353535
- Email: mhwu68@mail.ncku.edu.tw
-
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
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 |
Intervention / Treatment |
---|---|
Experimental: latic acid bacteria and cranberry
oral latic acid bacteria and cranberry capsule (dose of 2 * 10^9 cfu per capsule), one pill daily
|
oral lactobacillus capsule (dose of 2 * 10^9 cfu per capsule), one pill daily
oral cranberry capsule, one pill daily
|
Active Comparator: cranberry
oral cranberry capsule without lactic acid bacteria, one pill daily
|
oral cranberry capsule, one pill daily
|
Placebo Comparator: placebo
placebo without lactic acid bacteria and cranberry, one pill daily
|
placebo capsule without lactic acid bacteria and cranberry, one pill daily
|
What is the study measuring?
Primary Outcome Measures
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
Collaborators
Investigators
- 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
June 1, 2012
Primary Completion (Anticipated)
July 1, 2015
Study Completion (Anticipated)
July 1, 2015
Study Registration Dates
First Submitted
January 28, 2013
First Submitted That Met QC Criteria
January 28, 2013
First Posted (Estimate)
January 30, 2013
Study Record Updates
Last Update Posted (Estimate)
April 28, 2015
Last Update Submitted That Met QC Criteria
April 26, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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