Probiotic on Prevention of GBS Vaginal Infection During Pregnancy
Probiotic on Prevention of GBS Vaginal Infection During Pregnancy
The purpose of this study is to examine whether oral taking Lactobacillus rhamnosus GR-1 and
 Lactobacillus reuteri RC-14 from 28th week of gestation can reduce the GBS colonization rate
 of vagina and rectum in 35-37 weeks pregnant women as well as during laboring who present
 with GBS-positive at 28 weeks pregnancy. Through the results of our study, we try to
 investigate the role of probiotics in preventing the unnecessary tests, admission and
 antibiotic treatment in newborn with GBS-positive mother who deliver fewer than 4 hours after
 laboring and the influence of improving cervical diagnostics quality for postpartum Pap
 testing. Investigators hope the findings may have some effects on GBS sepsis and protocols as
 well as cervical diagnosis.
The Centers for Disease Control and Prevention(CDC) guideline in 2010 recommends minimum of 4
 hours of intrapartum antibiotics prophylaxis on GBS colonized pregnant women for preventing
 early-onset GBS infection of neonates. However, GBS-positive mothers who arrive at the labor
 floor and deliver in fewer than 4 hours is frequent, especially in multiparous mothers. This
 problem is not easily resolved by antibiotic treatment of the pathogen; thus, such
 traditional approaches need to be reevaluated. The administration of specific Lactobacilli
 strains by mouth or intravaginally has been shown to be safe and effective in reducing
 urogenital infections. Previous results have showed that GR-1 and RC-14 can decrease GBS
 colonization during the later stage of pregnancy, taking probiotics capsules after GBS test
 in 35 to 37 weeks pregnant is still have to follow GBS guideline by CDC in 2010 of use
 antibiotics before delivery. Studies showed the use of antibiotics during pregnancy
 influenced the GI flora of neonates. Non-antibiotics prophylaxis for preventing newborns' GBS
 infection and reduce GBS colonization in 35-37 week pregnant are meaningful.

 The raised estrogen and growth hormone during pregnancy may increase the activity of HPV
 molecule and human papilloma virus (HPV) infection. Short-time HPV persistence has been
 associated with higher risk for cervical intra-epithelial neoplasia and a higher risk of
 High-Grade Squamous Intraepithelial Lesion(HSIL). Clinical data showed GR-1 and RC-14 can
 improve the cervical malignancy diagnostics quality for non-pregnant women. The influence of
 oral probiotics on postpartum cervical diagnosis result is remain unknown.

 This study is a prospective double blind randomized clinical trial. Vaginal and rectal GBS
 test are carried out at 28 weeks of gestation. Subjects with GBS-positive are invited to
 participate in this study after informed consent. 200 pregnant women are randomly assigned to
 one of the two groups. The study group is treated with two oral capsules of probiotics once
 daily (before sleeping) for 18 weeks, and the control group will take 2 capsules of placebos.

 Vaginal and rectal GBS culture is repeated in 35-37 week of gestation and intrapartum period.
 All participators will treat according to GBS guideline by CDC in 2010. Cervical diagnosis
 will be completed at the 6th week after delivery. Through the results of this study,
 investigators try to investigate the role of probiotics in preventing the unnecessary tests,
 admission and antibiotic treatment in newborn with GBS positive mother who deliver fewer than
 4 hours after laboring and the influence of improving cervical diagnostics quality for
 postpartum Pap testing. Investigators hope the findings may have some effects on GBS sepsis
 and protocols and cervical diagnosis.
Inclusion Criteria:

 -  20-45 years old pregnant women

 -  Singleton pregnancy

 -  GBS positive confirmed on 28th week gestation with informed consent form

 -  Agreed to abstain from the use of any systemic or intra-vaginal antibiotic, antifungal
 agents, or any other intravaginal product(e.g., contraceptive creams, lubricants, and
 douches) throughout the trial period.

 Exclusion Criteria:

 -  Multiple gestations

 -  Impaired immunity, diabetes, or any other kind of significant disease or acute illness
 that could complicate the evaluation of the results

 -  Received vaginal or systemic antibiotics and antifungal therapy within 2 weeks of the
 screening visit

 -  Allergy or GI dysfunction history after taking probiotics or yogurt

 -  Constipation