Correlating Probiotic Dietary Supplements During Pregnancy With Maternal Microbiome Profiles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 6
- 主要终点
- Change in Vaginal Microbiome, 16S rRNA
研究概览
简要总结
The overarching goal of this project is to compare the microbiome profiles of healthy pregnant women, both before and after the introduction of a probiotic supplement into the maternal diet. Specifically, the investigators are performing a pilot randomized double-blinded placebo-controlled trial, comparing the microbiome profiles of 40 healthy pregnant women randomized to receive an oral probiotic containing a mixture of Lactobacillus and Bifidobacterium species (20 mothers) versus an oral placebo (20 mothers) during the first/second trimester of pregnancy. For each mother, the investigators will collect biospecimens from the vagina, rectum, and urine, both before intervention, and 4-6 weeks after intervention. These biospecimens will be analyzed to obtain their microbiome profiles using next-generation sequencing. The primary outcome of interest is the vaginal microbiome, with secondary outcomes including the microbiomes of the rectum and urine. Additionally, the investigators will collect clinical data from the mother's and infant's medical records to correlate our findings with pregnancy and postnatal outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant patients ≥ 18 years of age
- •Singleton pregnancy
- •Gestational age 6 weeks and 0 days through gestational age 13 weeks and 6 days
排除标准
- •Pregnant patients <18 years of age
- •Multiple gestations
- •Gestational age less than or equal to 5 weeks and 6 days
- •Gestational age greater than or equal to 14 weeks and 0 days
- •Institutionalization for psychiatric disorder, mental retardation, or criminal activity
- •Inability to provide informed consent
- •Major medical complication of pregnancy, including but not limited to: Diabetes, Chronic hypertension, Severe obesity with body mass index greater than or equal to 40 kg/m2
- •Major surgical complications of pregnancy, including but not limited to: History of Bariatric surgery
- •Major obstetrical complication of pregnancy, including but not limited to: History of spontaneous preterm birth
- •Known maternal or fetal chromosomal abnormality
- •Major fetal anomaly
- •Intrauterine fetal demise
- •Human immunodeficiency virus (HIV) or Hepatitis
- •Chronic immunosuppressive medications or steroids
- •Current use of probiotic supplementation
- •Active urinary or vaginal infection
- •Current use of antibiotics
- •Current use of vaginal medication (e.g. vaginal progesterone)
- •Cerclage in place
研究组 & 干预措施
Probiotic
干预措施: Probiotic (Dietary Supplement)
Placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change in Vaginal Microbiome, 16S rRNA
时间窗: Baseline, and 4-6 weeks after intervention
次要结局
- Change in Rectal Microbiome, 16S rRNA(Baseline, and 4-6 weeks after intervention)
- Change in Urinary Microbiome, 16S rRNA(Baseline, and 4-6 weeks after intervention)
研究者
Louise Laurent, MD/PhD
Director of Perinatal Research; Department of Obstetrics, Gynecology, and Reproductive Sciences; Division of Maternal-Fetal Medicine
University of California, San Diego