Oral Probiotics Reduce Group B Streptococci Colonization in Pregnant Women
Condition: Group B Streptococcal Infection
MeSH terms: Infections; Streptococcal Infections
Study type: Interventional

Summary: 
      The purpose of this study is to examine whether daily use of oral gelatin capsules containing
      dried viable Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 can reduce the GBS
      colonization rate of vagina and rectum in pregnant women who present with GBS-positive
      diagnosed by GBS culture at 35-37 weeks gestation.

      This study is a prospective double blind randomized clinical trial. Vaginal and rectal GBS
      screening culture are carried out for all pregnant women at 35-37 weeks of gestation in our
      out-patient department. Subjects with vagina and rectum GBS colonization are invited to
      participate in our study after informed consent. A total of 200 pregnant women will
      participate in the study during the 12-months trial period. They 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 14 days, and the control group will take 2 capsules of placebos.
      Vaginal and rectal GBS culture is repeated for all participators 2 weeks later. All
      participators will treated according to GBS guideline by CDC in 2002 during laboring.
    

Detailed description: 
      Group B streptococci (GBS) colonizes the vagina and rectum in 10-30% of pregnant women. In
      the newborn, GBS is a leading cause of neonatal sepsis and a major cause of pneumonia and
      meningitis. Intrapartum penicillin G prophylaxis aims to prevent early-onset group B
      streptococci (GBS) sepsis by interrupting vertical transmission. According to the Center of
      Disease Control and Prevention (CDC) guideline in 2002, a minimum of 4 hours of intrapartum
      antibiotics prophylaxis is generally recommended to prevent early-onset group B
      Streptococcous (GBS) because less than 4 hours may not achieve adequate levels drugs. Even
      with the most valiant of efforts, there will frequently be GBS-positive mothers who arrive at
      the labor floor and deliver in fewer than 4 hours, especially in multiparous mothers.
      Preliminary studies as well as data from a large health maintenance organization demonstrated
      the 40-50%of GBS-colonized women do not receive antibiotics at least 4 hours before delivery
      due the rapidity of their labors. Newborns of all GBS-positive women who present to labor
      units and deliver before receiving 4 hours of intrapartum antibiotic prophylaxis are deemed
      as "at risk" and recommended to undergo blood cultures, complete blood count, and 48 hours of
      observation. This problem is not easily resolved by antibiotic treatment of the pathogen;
      thus, such tranditional approaches to patient management need to be re-evaluated.

      Probiotics are defined as live micro-organisms which, when administered in an adequate
      amount, confer a health benefit on the host. Probiotics have been shown to displace and kill
      pathogens and modulate the immune response by interfering with the inflammatory cascade that
      leads to preterm labour and delivery. Lactobacilli are the dominant bacteria of vaginal flora
      and possess antimicrobial properties that regulate other urogenital microbiota. Incomplete
      cure and recurrence of genitourinary infections lead to a shift of the local flora from a
      predominance of lactobacilli to coliform uropathogens. Use of Lactobacillus-containing
      probiotics to restore commensal vaginal flora has been proposed for the treatment and
      prophylaxis of bacterial urogenital infections. The actual mechanism of action of probiotics
      in the vagina is probably multifactorial. The production of lactic acid, bacteriocin, and
      hydrogen peroxide seems to be important, and modulation of immunity is another possible
      mechanism. The administration of these Lactobacilli by mouth or intravaginally, or both has
      been shown to be safe and effective in reducing, or treating, or both, urogenital infections.
      For pregnant women, such restoration could be important to prevent BV and lower the risk of
      PTL Daily use of oral gelatin capsules containing dried viable Lactobacillus rhamnosus GR-1
      and Lactobacillus reuteri RC-14 has been shown to decreased e risk of bacterial vaginosis and
      maintain normal lactobacilli vaginal flora. These organisms are antagonistic to the growth
      and adhesion of various intestinal and urogenital pathogens including Salmonella typhimurium,
      Shigella sonnei, E coli 0157, toxic shock Staphylococcus aureus, group B streptococci,
      Enterococcus faecalis, G vaginalis, and uropathogenic E coli. In animal studies, these
      strains were found to be safe during pregnancy and to enhance the health of mothers and
      newborns. Studies are under way in Toronto, Ont, to test the effects of these strains on
      bacterial vaginosis in pregnant women at risk of preterm labour. These lactobacilli might
      also have a role in preventing vaginal colonization by group B streptococci, organisms that
      can cause serious illness and even death in newborns. Certain lactobacilli can inhibit growth
      and adhesion of streptococci in vitro, but whether they can do this in vivo is untested.

      This study is a prospective double blind randomized clinical trial. Vaginal and rectal GBS
      screening culture are carried out for all pregnant women at 35-37 weeks of gestation in our
      OPD. Subjects with vagina and rectum GBS colonization are invited to participate in our study
      after informed consent. A total of 200 pregnant women will participate in the study during
      the 12-months trial period. They 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 14
      days, and the control group will take 2 capsules of placebos. Vaginal and rectal GBS culture
      is repeated for all participators 2 weeks later. All participators will treated according to
      GBS guideline by CDC in 2002 during laboring.

      Much of the current literature has investigated the potential of probiotics in preventing of
      bacterial vaginosis and preterm labor, but the usefulness of using probiotics as a surrogate
      or adjunctive therapy for intra-partum antibiotics prophylaxis in GBS colonized pregnant
      women dose not have any. This is the first study to investigate the role of probiotics in
      preventing and treating vaginal colonization by GBS in pregnant women. The purpose of this
      study is to examine whether oral taking Latobacillus-containing probiotics can reduce the GBS
      colonization rate of vagina and rectum in pregnant women who present with GBS-positive.
      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. We hope our results may have some effects on
      GBS sepsis protocols.
    

Intervention name(s): Probiotic; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): oral taking 2 capsules before sleeping per day for 14 days; oral taking 2 capsules before sleeping per day for 14 days
Other intervention name(s): U-relax oral capsule, Lactobacillus GR-1 and RC-14; Placebo oral capsule
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: 31-32 Weeks of Gestation Completed; Group B Streptococcal Infection; Streptococcus Group B Infection of the Infant