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

August 14, 2018 updated by: Natali Aziz, Stanford University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
251

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Aptos, California, United States, 95003
        • Aptos Women's Health Center
      • Santa Cruz, California, United States, 95065
        • Dominican Hospital
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine/Lucile Packard Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Sugar pill

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Count of Participants With Positive Group B Streptococcus Rectovaginal Colonization Status at 35- 37 Weeks' Gestational Age
Time Frame: 35 to 37 weeks gestational age
Gestational age is given in a format of full weeks.
35 to 37 weeks gestational age

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Count of Participants With Urinary Tract Infection
Time Frame: From enrollment up to delivery hospitalization (up to 42 weeks gestation)
From enrollment up to delivery hospitalization (up to 42 weeks gestation)
Count of Participants With Intrapartum Chorioamnionitis
Time Frame: From time of labor onset until delivery (up to 42 weeks of gestation)
Intrapartum chorioamnionitis is maternal temperature above 38.0 degrees Celsius and one or more of the following findings: fetal tachycardia; maternal tachycardia; uterine tenderness; purulent or malodorous amniotic fluid, or elevated maternal white blood cell count.
From time of labor onset until delivery (up to 42 weeks of gestation)
Count of Participants With Endometritis
Time Frame: From time of delivery up to 6 weeks postpartum
Endometritis is a uterine (myometrial) infection.
From time of delivery up to 6 weeks postpartum
Count of Participants With Cellulitis
Time Frame: From time of delivery up to 6 weeks postpartum
Cellulitis is a bacterial skin infection.
From time of delivery up to 6 weeks postpartum
Count of Participants With Bacteremia
Time Frame: From time of labor onset up to 6 weeks postpartum
Bacteremia is defined as presence of bacteria in the blood.
From time of labor onset up to 6 weeks postpartum
Count of Participants With Sepsis
Time Frame: From labor onset up to 6 weeks postpartum
Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated response of the body to an infection.
From labor onset up to 6 weeks postpartum
Count of Participants With Other Infectious Morbidity
Time Frame: From time of labor onset up to 6 weeks postpartum
Other infectious morbidity included maternal mastitis or pneumonia.
From time of labor onset up to 6 weeks postpartum
Gestational Age at Delivery
Time Frame: At time of delivery (up to 42 weeks of gestation)
Gestational age at delivery is presented as weeks.
At time of delivery (up to 42 weeks of gestation)
Apgar Score at 1 and 5 Minutes Following Delivery
Time Frame: At time of delivery (up to 42 weeks of gestation)
Apgar score is a measure to quickly assess the neonatal health status from time of delivery. Score ranges from 0-10. Lower scores correspond to worse health state; neonates with scores below 5 are considered to have poor prognosis.
At time of delivery (up to 42 weeks of gestation)
Neonatal Bilirubin Level
Time Frame: Up to 14 days following delivery
Up to 14 days following delivery
Neonatal C-reactive Protein Level
Time Frame: Up to 14 days following delivery
Maximum neonatal C-reactive protein level
Up to 14 days following delivery
Count of Neonates Requiring a "Rule-out Sepsis Evaluation"
Time Frame: Up to 14 days following delivery
Outcome was based on performance of neonatal blood culture.
Up to 14 days following delivery
Count of Neonates With Sepsis
Time Frame: Up to 14 days following delivery
Up to 14 days following delivery
Count of Neonates With Pneumonia
Time Frame: Up to 14 days following delivery
Up to 14 days following delivery
Count of Neonates With Meningitis
Time Frame: Up to 14 days following delivery
Up to 14 days following delivery
Count of Neonates With Intensive-care Unit Admission
Time Frame: Up to 14 days following delivery
Up to 14 days following delivery
Length of Neonatal Hospital Stay
Time Frame: Up to 14 days following delivery
Up to 14 days following delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stanford University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Natali Aziz, MD, Stanford University School of Medicine/Lucile Packard Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 26, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 26, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 24, 2011

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18840

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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