Trial Search Results
Effects of Oral Probiotic Supplementation on Group B Strep (GBS) Rectovaginal Colonization in Pregnancy
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.
Stanford is currently accepting patients for this trial.
- Dietary Supplement: Placebo
- Dietary Supplement: Probiotic dietary supplement
Phase 1/Phase 2
1. Pregnant women between 20-28 weeks gestation.
2. 18 years of age or older.
3. Singleton gestation.
1. Preexisting morbidity: Immunocompromised status (HIV +; malignancy; history of organ
transplant; chronic steroid therapy; autoimmune disease requiring treatment during
pregnancy, and other immunocompromised states); Type 1 diabetes and type 2
diabetes;congenital cardiac disease and cardiac valvular disease requiring antibiotic
prophylaxis during procedure/labor; pulmonary disease (except mild asthma); renal
disease; chronic hepatic disease (Hepatitis B, C); inflammatory bowel disease (Crohn's
disease or ulcerative colitis); stomach or duodenal ulcer; bowel resection, gastric
bypass, and chronic indwelling venous, bladder, or gastric catheter.
2. Multi-fetal gestation.
3. Use of probiotics preparations in the 3 months prior to beginning of the study
treatment or use of any additional probiotics preparations (other than study
treatment) at any time during the study period (including over the counter food
supplements such as Activia, BioK, other oral or vaginal probiotics products (BUT not
including other common forms of yogurt).
4. Chronic (daily) use of broad spectrum antibiotics.
5. History of infant with GBS sepsis.
6. Intrauterine Growth Restriction (IUGR), Fetal Anomalies-major diagnosed at time of
second trimester anatomy ultrasound
7. Anticipated delivery <35 wks for maternal/fetal indication
8. Placenta previa or accreta (with anticipated delivery prior to 35 weeks)
Ages Eligible for Study
18 Years - 55 Years
Genders Eligible for Study