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

Completed · Not applicable · Has a placebo group

Conditions studied: Infection, Pregnancy

In brief

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.

Key facts

Study ID

NCT01479478

Run by

Stanford University

People needed

251

Starts

2011-11-01

Expected to finish

2017-07-26

Last updated by the study team

2018-08-20

Who can join

Age: 18 and older, up to 55. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Pregnant women between 20-28 weeks gestation.
• 18 years of age or older.
• Singleton gestation.

You may not qualify if…

• 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
• Placenta previa or accreta (with anticipated delivery prior to 35 weeks)

Where it is running

• Aptos Women's Health Center — Aptos, California, United States
• Dominican Hospital — Santa Cruz, California, United States
• Stanford University School of Medicine/Lucile Packard Children's Hospital — Stanford, California, United States

Full record on ClinicalTrials.gov

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