Validation of the In-utero Transmission of Probiotics From the Mother to the Baby: A Randomized Crossover Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- in-utero transmission of probiotic
研究概览
简要总结
This pilot project aims at confirming the in-utero transmission of probiotics, from the mother to the baby. Women aged 18 to 42 years, with a single pregnancy, considered low risk will be approached for this study. Women will take the investigational products between 34 weeks of pregnancy up to 10 days post-partum. Investigational products are probiotics (5 bacterial strains) compared to placebo.
详细描述
Rational: Studies have shown that probiotics given to babies can reduce perinatal complications. A change of practice should therefore be introduced in the management of premature newborns. However, one could assume that probiotic administration before birth could be as effective if not more. Indeed, one could hypothesise that when the newborn is exposed to probiotics earlier, the protective effect is potentially increased.
Objective: This pilot project aims at confirming the in-utero transmission of probiotics, from the mother to the baby.
Population: Women aged 18 to 42 years, with a single pregnancy, considered low risk will be approached for this study Products under study: Probiotics containing 5 bacterial strains (total of 12 million colony-forming unit / day) vs. Placebo.
Procedure: At 32-33 weeks, participants will complete questionnaires (medical, obstetrical, socio-demographic data) and will be randomized (double-blind) in one of the 2 following groups:
Group A: taking probiotics every day from the 34th week of pregnancy until delivery; taking placebo for 10 days after delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double-blinded
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with a single pregnancy
- •Women with a low risk pregnancy
- •Women wishing to breastfeed at birth
- •Women randomized between 32 0/7 - 33 6/7 weeks of gestation
排除标准
- •History of obstetric complications (prematurity <37 weeks, preeclampsia , gestational diabetes treated with insulin)
- •Obstetric or fetal complications known for current pregnancy such as threaten preterm labor (premature rupture of membranes or preterm labor), chorioamnionitis, placenta previa, active vaginal bleeding, cervical cerclage, fetal distress or anomalies, corticosteroid therapy
- •Risk factors for obstetric complications during current pregnancy such as gestational diabetes, type I / II diabetes and high blood pressure (systole ≥140 and diastole ≥90)
- •Antibiotic use within 2 weeks before randomisation
- •Intake of probiotics or foods enriched with active cultures (fermented milk, kefir, kombucha ...) within 2 weeks before randomisation
- •Women positive for Group B Streptococcus during previous pregnancies
- •Weakened immune system (AIDS, lymphoma, chemoradiotherapy or corticotherapy, immunosuppressive pathology)
- •Allergy or intolerance to lactose, soy or yeast.
- •Women under Coumadin
- •Women who plan to give birth outside the participating center
- •Women who do not plan to breastfeed or extract their milk in the first 10 days after delivery.
结局指标
主要结局
in-utero transmission of probiotic
时间窗: at birth
presence (yes or no) of probiotic (specific bacterial strains) in neonate meconium
次要结局
- postnatal transmission of probiotic to the neonate(10 days postpartum)
- transmission of probiotic to colostrum(at birth)
- transmission of probiotic to maternal milk(10 days postpartum)
- transmission of probiotic to maternal vaginal tract(37 weeks of gestation)
- transmission of probiotic to maternal gut(37 weeks of gestation)