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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01479478
First received: November 22, 2011
Last updated: July 8, 2013
Last verified: July 2013
  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.


Condition Intervention Phase
Infection
Pregnancy
Dietary Supplement: Placebo
Dietary Supplement: Probiotic dietary supplement
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Group B Streptococcus rectovaginal colonization [ Time Frame: 35 to 37 weeks gestational age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of obstetric and neonatal outcomes between probiotic and placebo group [ Time Frame: 6 weeks post partum ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 372
Study Start Date: November 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Dietary Supplement: Placebo
One placebo capsule daily.
Other Name: Sugar pill

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.
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01479478

Contacts
Contact: Natali Aziz, MD 650-724-8222 naziz@stanford.edu

Locations
United States, California
Stanford University School of Medicine/Lucile Packard Children's Hospital Recruiting
Stanford, California, United States, 94305
Principal Investigator: Natali Aziz, MD, MS         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Natali Aziz, MD Stanford University School of Medicine/Lucile Packard Children's Hospital
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01479478     History of Changes
Other Study ID Numbers: 18840
Study First Received: November 22, 2011
Last Updated: July 8, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 19, 2014