NCT01479478已完成不适用
Oral Probiotic Supplementation and Group B Streptococcus Rectovaginal Colonization in Pregnant Women: a Randomized Double-blind Placebo-controlled Trial.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 251
- 试验地点
- 3
- 主要终点
- Count of Participants With Positive Group B Streptococcus Rectovaginal Colonization Status at 35- 37 Weeks' Gestational Age
研究概览
简要总结
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.
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women between 20-28 weeks gestation.
- •18 years of age or older.
- •Singleton gestation.
排除标准
- •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)
研究组 & 干预措施
Probiotic dietary supplement
Active Comparator
Probiotic dietary supplement one capsule once per day until delivery.
干预措施: Probiotic dietary supplement (Dietary Supplement)
Placebo
Placebo Comparator
Placebo capsule, one daily until delivery.
干预措施: Placebo (Drug)
结局指标
主要结局
Count of Participants With Positive Group B Streptococcus Rectovaginal Colonization Status at 35- 37 Weeks' Gestational Age
时间窗: 35 to 37 weeks gestational age
Gestational age is given in a format of full weeks.
次要结局
- Count of Neonates Requiring a "Rule-out Sepsis Evaluation"(Up to 14 days following delivery)
- Count of Participants With Urinary Tract Infection(From enrollment up to delivery hospitalization (up to 42 weeks gestation))
- Neonatal Bilirubin Level(Up to 14 days following delivery)
- Length of Neonatal Hospital Stay(Up to 14 days following delivery)
- Count of Participants With Intrapartum Chorioamnionitis(From time of labor onset until delivery (up to 42 weeks of gestation))
- Count of Participants With Endometritis(From time of delivery up to 6 weeks postpartum)
- Count of Participants With Cellulitis(From time of delivery up to 6 weeks postpartum)
- Gestational Age at Delivery(At time of delivery (up to 42 weeks of gestation))
- Apgar Score at 1 and 5 Minutes Following Delivery(At time of delivery (up to 42 weeks of gestation))
- Count of Neonates With Pneumonia(Up to 14 days following delivery)
- Count of Participants With Bacteremia(From time of labor onset up to 6 weeks postpartum)
- Count of Participants With Sepsis(From labor onset up to 6 weeks postpartum)
- Neonatal C-reactive Protein Level(Up to 14 days following delivery)
- Count of Neonates With Sepsis(Up to 14 days following delivery)
- Count of Neonates With Intensive-care Unit Admission(Up to 14 days following delivery)
- Count of Participants With Other Infectious Morbidity(From time of labor onset up to 6 weeks postpartum)
- Count of Neonates With Meningitis(Up to 14 days following delivery)
研究者
Natali Aziz
Clinical Assistant Professor
Stanford University
研究点 (3)
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