Effects of Oral Probiotic Supplementation on Group B Strep (GBS) Rectovaginal Colonization in Pregnancy
Condition: Infection; Pregnancy
Study type: Interventional

Summary: 
      The investigators wish to determine if oral probiotic supplementation during the second half
      of pregnancy decreases maternal GBS recto-vaginal colonization at 35-37 weeks' gestational
      age, thereby decreasing need for maternal antibiotic administration at time of labor. The
      importance of this study is that it may offer a safer alternative to antibiotic treatment of
      group B Streptococcus (GBS) colonized pregnant women.
    

Detailed description: 
      1. Screening: All pregnant women prior to 28 weeks gestational age. Patients who choose to
           enroll and who will not deliver at Lucile Packard Childrens Hospital at Stanford will
           sign release of medical information forms for study personnel to access pregnancy
           outcomes. Patients receiving obstetric care at any of the satellite research sites in
           Santa Cruz will also be offered enrollment in the study.

        2. Women will continue regular and routine obstetric care and clinic visits.

        3. Placebo vs probiotic daily regimen: We plan to begin administration of product and
           placebo at 20 weeks gestation, and no later than 28 weeks gestation until delivery. Once
           a women is enrolled in the study, she will be randomized to either the placebo or the
           probiotic group.

        4. At the time of randomization, the patient will receive her month supply of 30 capsules;
           The allocation arm will be double-blinded.

        5. The investigators will schedule the women for routine monthly obstetric visits (more
           often if clinically required) during which time they will also meet with one of the
           investigators. The investigator at each monthly visit will provide an additional monthly
           allotment of 30 capsules. The capsule bottle from the previous cycle will be collected
           and dated if there are capsules remaining in the bottle. Remaining capsules will be
           counted and refrigerated for future use.

        6. The investigators will collect history data including safety data per the questionnaire
           and will document compliance with the study.

        7. GBS recto-vaginal screening: The investigators will enroll the women in the study and we
           will perform the standard GBS colonization screening (using standard GBS recto-vaginal
           cultures) at 36 weeks.

        8. Additionally, subjects may opt to have serial vaginal swabs collected to assess
           potential beneficial effects of probiotics on the vaginal microbiota and bacterial
           vaginosis (BV) status. Vaginal swabs will be collected (either by study personnel or
           self-collected by the study participant). Swabs will be inserted 1-2 inches into the
           vaginal introitus and spun for 20 seconds and then withdrawn. Swabs will be collected at
           the following time points: prior to probiotic/placebo initiation, every 1-4 weeks from
           time of enrollment to time of delivery, and postpartum serially up to 12 months. These
           swabs will be stored at -20 degrees Celsius or colder for additional microbiologic
           analyses.

        9. Additionally, placental tissue may be collected at time of delivery for possible future
           microbiome and/or other analyses.

       10. Women who suffer a premature rupture of the membranes, deliver before 36 weeks
           gestation, or go into labor before the GBS culture result is available, will receive the
           standard GBS antibiotic prophylaxis.

       11. Labor: The patient will receive standard delivery and newborn care. Patients with a
           positive GBS culture will be treated with standard antibiotics in labor.

       12. Postpartum and neonatal care: The patient will receive routine postpartum care per the
           obstetric team. Data regarding her postpartum course and neonatal outcomes will be
           collected.
    

Intervention name(s): Placebo; Probiotic dietary supplement
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): One placebo capsule daily.; Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14
Other intervention name(s): Sugar pill; Other Names:; Jarrow's fem-dophilus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention