Probiotic on Prevention of GBS Vaginal Infection During Pregnancy
Condition: Infection, Bacterial
MeSH terms: Infections; Communicable Diseases; Bacterial Infections
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Probiotic capsule GR-1 and RC-14; Placebo capsule
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Study Group will take 2 probiotics capsules containing 1 billion colony forming unit(CFU) of Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 each before sleep for 18 weeks starting at 28th week gestation; Placebo Group will take 2 placebo capsules before sleep for 18 weeks starting at 28th week gestation
Other intervention name(s): U-relax
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study Group: take 2 probiotics capsules before sleep for 12 weeks after being confirmed as GBS positive on 28th gestation Placebo Group: take 2 placebo capsules before sleep for 12 weeks after being confirmed as GBS positive on 28th gestation
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Probiotics; Group B Streptococcus; Infection; Prevention