Effects of Oral Probiotic Supplementation on Group B Strep (GBS) Rectovaginal Colonization in Pregnancy
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|ClinicalTrials.gov Identifier: NCT01479478|
Recruitment Status : Recruiting
First Posted : November 24, 2011
Last Update Posted : October 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Infection Pregnancy||Dietary Supplement: Placebo Dietary Supplement: Probiotic dietary supplement||Phase 1 Phase 2|
- 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.
- Women will continue regular and routine obstetric care and clinic visits.
- 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.
- At the time of randomization, the patient will receive her month supply of 30 capsules; The allocation arm will be double-blinded.
- 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.
- The investigators will collect history data including safety data per the questionnaire and will document compliance with the study.
- 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.
- 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.
- Additionally, placental tissue may be collected at time of delivery for possible future microbiome and/or other analyses.
- 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.
- Labor: The patient will receive standard delivery and newborn care. Patients with a positive GBS culture will be treated with standard antibiotics in labor.
- 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)|
|Estimated Enrollment :||372 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||November 2019|
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
Placebo Comparator: Placebo
Placebo capsule, one daily until delivery.
Dietary Supplement: Placebo
One placebo capsule daily.
Other Name: Sugar pill
- Group B Streptococcus rectovaginal colonization [ Time Frame: 35 to 37 weeks gestational age ]
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01479478
|Contact: Natali Aziz, MDemail@example.com|
|Contact: Anna Girsen, PhDfirstname.lastname@example.org|
|United States, California|
|Aptos Women's Health Center||Recruiting|
|Aptos, California, United States, 95003|
|Contact: Alexandra Klikoff, MD 831-688-8266|
|Contact: Karen Erlich email@example.com|
|Santa Cruz, California, United States, 95065|
|Contact: Mark Taslimi, MD|
|Contact: Karen Erlich firstname.lastname@example.org|
|Stanford University School of Medicine/Lucile Packard Children's Hospital||Recruiting|
|Stanford, California, United States, 94305|
|Contact: Anna Girsen, PhD 650-725-5720 email@example.com|
|Contact: Ariana Spiegel, BA 650-725-5720 firstname.lastname@example.org|
|Principal Investigator: Natali Aziz, MD, MS|
|Sub-Investigator: Mark Taslimi, MD|
|Principal Investigator:||Natali Aziz, MD||Stanford University School of Medicine/Lucile Packard Children's Hospital|