Modulation of the Intestinal Flora With the Probiotic VIVOMIXX™ in Pregnant Women at Risk of Metabolic Complications
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 205
- 试验地点
- 2
- 主要终点
- Maternal and newborn fecal microbiota changes (bifidobacteria and lactobacilli) and related enzymatic activity (alkaline sphingomyelinase and alkaline phosphatase) modifications
研究概览
简要总结
The investigators aimed at evaluating the effectiveness of probiotics ingestion in changing maternal microbiota and preventing gestational diabetes in overweight and obese women.
To achieve these goals, obese (BMI> 30 kg/m^2) or overweight (BMI> 25 kg/m^2) pregnant women with risk factors were enrolled in the study and randomized to the supplementation with the probiotic VIVOMIXX® or with placebo.
The endpoints of this study are to evaluate if the dietary supplementation with the probiotic VIVOMIXX® modifies the maternal fecal microbiota (bifidobacteria and lactobacilli) and related enzymatic activity (alkaline sphingomyelinase and alkaline phosphatase), and if this if this is linked to an improvement of the intermediate metabolism (positive Oral Glucose Tolerance Test at 24-26 weeks).
详细描述
This is a prospective, multicenter, randomized, double-blind, placebo-controlled trial.
208 pregnant women from the recruiting centers will be enrolled as follow: Women eligible to participate, prior informed consent, will be randomized to 2 capsules twice daily before breakfast and before dinner from randomization until delivery. The boxes will be given to the patients coded and blinded to investigators and participants, and will contain either the active ingredient (VIVOMIXX®, a mixture of 112 billion of eight strains for each capsule, namely Streptococcus thermophilus, bifidobacteria (B. breve, B. longum, B. infantis) and lactobacilli (L. paracasei, L. acidophilus, L. delbrueckii subsp bulgaricus, L. plantarum) or placebo.
The protocol includes a screening visit (Visit 1) at 10-12 weeks, two visits during pregnancy (at 26-28 weeks= Visit 2, and at 36-38 weeks=Visit 3) and a postnatal visit (2-3 days after delivery=Visit 4).
Eligible women should take two capsules twice daily (2 in the morning and 2 in the evening). Patients will be randomly assigned to the control or the VIVOMIXX® group.
The study agent VIVOMIXX® as well as the placebo will be supplied by "Mendes SA" for the whole study period.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged between 20 and 40 with singleton pregnancies and BMI at recruitment > 30 kg/m^2 or a BMI> 25 kg/m^2 and the simultaneous presence of at least 1 of the following risk factors: age> 35 years, previous fetal macrosomia (> 4500gr), family history of diabetes (first-degree relative with type 2 diabetes mellitus), previous gestational diabetes mellitus.
- •Adherence to lifestyle prescription including dietary counselling and physical activity stimulation
排除标准
- •Subjects who require intervention in addition to the lifestyle changes women with diet and habits much different from the Mediterranean area (Central Africa, Asian, etc..). In such subgroup it will be difficult to obtain adherence to diet prescription since their cultural attitudes and dietary habits.
- •Pre-pregnancy BMI> 40 kg/m^2
- •Chronic hypertension
- •Fasting glycemia in the first trimester of> 126 mg / dl or random glycemia > 200 mg/dl
结局指标
主要结局
Maternal and newborn fecal microbiota changes (bifidobacteria and lactobacilli) and related enzymatic activity (alkaline sphingomyelinase and alkaline phosphatase) modifications
时间窗: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
NMR-based metabolomics, microbiota and high performance liquid chromatography-mass spectrometry -HPLC/MS- of vitamins analysis
Glucose metabolism changes
时间窗: At 24-26 week
Positive Oral Glucose Tolerance Test
次要结局
- homocysteine plasmatic levels(At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery)
- Duration of sleep(At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery)
- Mode of delivery(At delivery)
- Weight changes(At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery)
- Maternal BMI(At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery)
- Waist/hip circumference ratio(At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery)
- Gestational weight gain(At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery)
- HOMA Index(At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery)
- HbA1c1(At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery)
- Quality of sleep(At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery)
- Complications during delivery(At delivery)
- Newborn's weight(Within 1 hour after delivery)
- Apgar score(Within 1 hour after delivery)
- glycemia(At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery)
- insulinemia(At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery)
- Newborn's skinfold thickness at birth(2-3 days after delivery)
- Neonatal hypoglycemia(Within 24 hours from delivery)
- Onset of hypertension / preeclampsia(At delivery)
- Time of delivery(At delivery)
- Newborn's abdomen / head ratio(2-3 days after delivery)
- Neonatal bilirubinemia(At delivery, 2-3 days after delivery)
- Neonatal complications(2-3 days after delivery)
- Newborn's sex(Within 1 hour after delivery)
- Requirement for insulin therapy(At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery)
- Admission to Neonatal Intensive Care Unit (NICU)(Within 24 hours after delivery)
研究者
Prof. Facchinetti Fabio
Chairman of Obstetrics and Gynecology Unit
University of Modena and Reggio Emilia