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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01479478
Recruitment Status : Completed
First Posted : November 24, 2011
Last Update Posted : April 19, 2018
Information provided by (Responsible Party):
Natali Aziz, Stanford University

Brief 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.

Condition or disease Intervention/treatment Phase
Infection Pregnancy Drug: Placebo Dietary Supplement: Probiotic dietary supplement Not Applicable

Detailed Description:
  1. Screening: All pregnant women prior to 28 weeks gestational age. Patients who choose to enroll and who will not deliver at Lucile Packard Childrens Hospital at Stanford will sign release of medical information forms for study personnel to access pregnancy outcomes. Patients receiving obstetric care at any of the satellite research sites in Santa Cruz will also be offered enrollment in the study.
  2. Women will continue regular and routine obstetric care and clinic visits.
  3. Placebo vs probiotic daily regimen: We plan to begin administration of product and placebo at 20 weeks gestation, and no later than 28 weeks gestation until delivery. Once a women is enrolled in the study, she will be randomized to either the placebo or the probiotic group.
  4. At the time of randomization, the patient will receive her month supply of 30 capsules; The allocation arm will be double-blinded.
  5. The investigators will schedule the women for routine monthly obstetric visits (more often if clinically required) during which time they will also meet with one of the investigators. The investigator at each monthly visit will provide an additional monthly allotment of 30 capsules. The capsule bottle from the previous cycle will be collected and dated if there are capsules remaining in the bottle. Remaining capsules will be counted and refrigerated for future use.
  6. The investigators will collect history data including safety data per the questionnaire and will document compliance with the study.
  7. GBS recto-vaginal screening: The investigators will enroll the women in the study and we will perform the standard GBS colonization screening (using standard GBS recto-vaginal cultures) at 36 weeks.
  8. Additionally, subjects may opt to have serial vaginal swabs collected to assess potential beneficial effects of probiotics on the vaginal microbiota and bacterial vaginosis (BV) status. Vaginal swabs will be collected (either by study personnel or self-collected by the study participant). Swabs will be inserted 1-2 inches into the vaginal introitus and spun for 20 seconds and then withdrawn. Swabs will be collected at the following time points: prior to probiotic/placebo initiation, every 1-4 weeks from time of enrollment to time of delivery, and postpartum serially up to 12 months. These swabs will be stored at -20 degrees Celsius or colder for additional microbiologic analyses.
  9. Additionally, placental tissue may be collected at time of delivery for possible future microbiome and/or other analyses.
  10. Women who suffer a premature rupture of the membranes, deliver before 36 weeks gestation, or go into labor before the GBS culture result is available, will receive the standard GBS antibiotic prophylaxis.
  11. Labor: The patient will receive standard delivery and newborn care. Patients with a positive GBS culture will be treated with standard antibiotics in labor.
  12. Postpartum and neonatal care: The patient will receive routine postpartum care per the obstetric team. Data regarding her postpartum course and neonatal outcomes will be collected.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 251 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Oral Probiotic Supplementation and Group B Streptococcus Rectovaginal Colonization in Pregnant Women: a Randomized Double-blind Placebo-controlled Trial.
Study Start Date : November 2011
Actual Primary Completion Date : July 26, 2017
Actual Study Completion Date : July 26, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Probiotic dietary supplement
Probiotic dietary supplement one capsule once per day until delivery.
Dietary Supplement: Probiotic dietary supplement
Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14
Other Names:
  • Other Names:
  • Jarrow's fem-dophilus

Placebo Comparator: Placebo
Placebo capsule, one daily until delivery.
Drug: Placebo
One placebo capsule daily.
Other Name: Sugar pill

Primary Outcome Measures :
  1. Group B Streptococcus rectovaginal colonization [ Time Frame: 35 to 37 weeks gestational age ]

Secondary Outcome Measures :
  1. Comparison of obstetric and neonatal outcomes between probiotic and placebo group [ Time Frame: 6 weeks post partum ]
    Secondary Outcomes to be assessed: maternal ante- intra- and postpartum outcomes (urinary tract infections, chorioamnionitis, endometritis, cellulitis, bacteremia, sepsis, and other infectious morbidity) and neonatal outcomes (gestational age at delivery, APGAR scores, bilirubin levels, C-reactive protein, rule out sepsis evaluation, sepsis, pneumonia, meningitis, neonatal ICU admission, and length of hospital stay).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01479478

United States, California
Aptos Women's Health Center
Aptos, California, United States, 95003
Dominican Hospital
Santa Cruz, California, United States, 95065
Stanford University School of Medicine/Lucile Packard Children's Hospital
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Principal Investigator: Natali Aziz, MD Stanford University School of Medicine/Lucile Packard Children's Hospital

Responsible Party: Natali Aziz, Clinical Assistant Professor, Stanford University Identifier: NCT01479478     History of Changes
Other Study ID Numbers: 18840
First Posted: November 24, 2011    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No