Effects of Oral Probiotic Supplementation on Group B Strep (GBS) Rectovaginal Colonization in Pregnancy

Not Recruiting

Trial ID: NCT01479478

Purpose

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.

Official Title

Oral Probiotic Supplementation and Group B Streptococcus Rectovaginal Colonization in Pregnant Women: a Randomized Double-blind Placebo-controlled Trial.

Stanford Investigator(s)

Natali Aziz, M.D., M.S.
Natali Aziz, M.D., M.S.

Clinical Associate Professor, Obstetrics & Gynecology - Maternal Fetal Medicine

Eligibility


Inclusion Criteria:

   1. Pregnant women between 20-28 weeks gestation.

   2. 18 years of age or older.

   3. Singleton gestation.

Exclusion Criteria:

   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)

Intervention(s):

dietary supplement: Probiotic dietary supplement

drug: Placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cynthia Willson, RN
650-724-6372