Effects of Oral Probiotic Supplementation on Group B Strep (GBS) Rectovaginal Colonization in Pre… (NCT01479478) | Clinical Trial Compass
CompletedNot Applicable
Effects of Oral Probiotic Supplementation on Group B Strep (GBS) Rectovaginal Colonization in Pregnancy
United States251 participantsStarted 2011-11
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexFEMALE
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Inclusion criteria
✓. Pregnant women between 20-28 weeks gestation.
✓. 18 years of age or older.
✓. Singleton gestation.
Exclusion criteria
✕. 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.
✕. Multi-fetal gestation.
✕. 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).
✕. Chronic (daily) use of broad spectrum antibiotics.
✕. History of infant with GBS sepsis.
✕. Intrauterine Growth Restriction (IUGR), Fetal Anomalies-major diagnosed at time of second trimester anatomy ultrasound
✕. Anticipated delivery \<35 wks for maternal/fetal indication
What they're measuring
1
Count of Participants With Positive Group B Streptococcus Rectovaginal Colonization Status at 35- 37 Weeks' Gestational Age