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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by National Cheng-Kung University Hospital
Sponsor:
Collaborator:
National Cheng-Kung University Hospital
Information provided by (Responsible Party):
Meng-Hsing Wu, National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier:
NCT01779193
First received: January 28, 2013
Last updated: April 30, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Pregnancy
Dietary Supplement: lactic acid bacteria
Dietary Supplement: cranberry
Dietary Supplement: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind,Randomized,Parallel,Placebo-controlled Study of Probiotics Capsule as Supplemental Therapy for Group B Streptococci Infection and Vaginitis During Pregnancy

Resource links provided by NLM:


Further study details as provided by National Cheng-Kung University Hospital:

Primary Outcome Measures:
  • all cases vaginal group B streptococcus colonies [ Time Frame: four years ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: June 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01779193

Contacts
Contact: Meng-Hsing Wu, M.D., Ph.D. +88662353535 ext 5222 mhwu68@mail.ncku.edu.tw

Locations
Taiwan
Department of Obstetrics and Gynecology, College of Medicine, National Cheng Kung University Recruiting
Tainan, Taiwan
Contact: Meng-Hsing Wu, M.D., Ph.D.    +88662353535 ext 5222    mhwu68@mail.ncku.edu.tw   
Principal Investigator: Meng-Hsing Wu, M.D., Ph.D.         
Sponsors and Collaborators
Meng-Hsing Wu
National Cheng-Kung University Hospital
Investigators
Principal Investigator: Meng-Hsing Wu, M.D., Ph.D. National Cheng Kung University
  More Information

No publications provided

Responsible Party: Meng-Hsing Wu, National Cheng Kung University Hospital (NCKUH) Department of Obstetrics and Gynecology, National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT01779193     History of Changes
Other Study ID Numbers: A-BR-101-065
Study First Received: January 28, 2013
Last Updated: April 30, 2013
Health Authority: Taiwan: Institutional Review Board

Keywords provided by National Cheng-Kung University Hospital:
group B streptococcus
pregnancy
probiotics

Additional relevant MeSH terms:
Streptococcal Infections
Vaginitis
Gram-Positive Bacterial Infections
Bacterial Infections
Vaginal Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 27, 2014