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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.
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