Effects of Probiotic Use During Pregnancy on Lactobacillus and Group B Streptococcus Vaginal Colonization: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Prenatal group B Streptococcus Colonization
研究概览
简要总结
This pilot quasi experiment was designed to determine the feasibility of a randomized controlled trial of the oral probiotic combination of Florajen3 (>7.5 x109 L. acidophilus, >6.0 x109. B. lactis, and >1.5 x109 B. longum) taken orally once daily beginning at 28 weeks gestation, against placebo, to reduce the colonization of group B Streptococcus at 36 weeks.
详细描述
Methods
A non-blinded, open-label, quasi-experimental design was approved by the Institutional Review Boards of three institutions (two universities and the clinical research site). The study setting was a large Certified Nurse-Midwife (subsequently referred to as midwife) clinical practice serving a culturally and economically diverse urban population in the Midwest region of the USA.
Participants Women self-selected to participate in screening and informed consent procedures done by the first two authors. The following inclusion criteria were used at study enrollment: low risk (no obstetric, fetal, medical or genetic risk factors), adult (≥18 years of age), pregnant at 28 ± 2 weeks gestation, able to speak and write English, and expressing willingness to participate in the study intervention (oral probiotic) and data collection (vaginal and rectal swabs, questionnaires).
A convenience sample of 20 healthy pregnant participants was sought. Following informed consent, the first 10 subjects were assigned to the experimental group. Nonrandom assignment was used to assure that the 10 experimental group participants were enrolled while remaining within funding, and time constraints. After enrolling the experimental group, the next ten women were assigned to the control group.
Intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Low risk pregnancy (no obstetric, fetal, medical or genetic risk factors)
- •Adult (≥18 years of age)
- •Pregnant at 28 ± 2 weeks gestation
- •Able to speak and write English
- •Willingness to participate in the study intervention (oral probiotic) and data collection (including vaginal and rectal swabs and questionnaires)
排除标准
- •Pregnant women with obstetric, fetal, medical, or genetic risk factors.
- •<18 years of age
结局指标
主要结局
Prenatal group B Streptococcus Colonization
时间窗: 36 weeks gestation
Routine prenatal GBS cultures were collected on all study participants at 35-37 weeks gestation as per the 2010 CDC GBS prevention guidelines. Only this result was use to determined the need for intrapartum antibiotic prophylaxis. All study participants received separate vaginal and rectal GBS culture swabs that were analyzed quantitatively for GBS/swab in Colony Forming Units (CFUs). These results were blind to the prenatal care providers.
次要结局
- Recruitment and retention of a diverse sample.(28 to 36 weeks gestation)
研究者
Lisa Hanson
Associate Professor
Marquette University