The Effect of Nutrition on the Microbiome in Pregnant Women and the Use of Micronutrient Supplemented Probiotic Yogurt to Improve Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Characterization of gut, oral, vaginal and human milk microbiomes
研究概览
简要总结
The purpose of this study is to determine whether a difference exists in the gut, oral, vaginal and human milk microbiome of under-nourished pregnant women as compared to healthy and obese pregnant women. In addition, the investigators are setting out to determine if a micronutrient enriched probiotic yogurt can improve the microbiome and pregnancy outcomes of under-nourished pregnant women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
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
- •Greater than 12 weeks pregnant
- •between the ages of 18 and 40 years
排除标准
- •Less than 12 weeks pregnant
研究组 & 干预措施
Undernourished Pregnant Women
Pregnant women who are classified as undernourished
Nourished Pregnant Women
Pregnant women who are classified as healthy
Overweight/obese Pregnant women
Pregnant women who are classified as obese or overweight
Undernourished + Yogurt Pregnant Women
Pregnant women who are undernourished and selected to receive Moringa and Lactobacillus rhamnosus GR-1 probiotic yogurt. Yogurt contained 4.3 grams of Moringa and 10^8 CFU/mL of Lactobacillus rhamnosus GR-1 as well as Streptococcus thermophilus and Lactobacillus bulgaricus starter cultures.
干预措施: Moringa and Lactobacillus rhamnosus GR-1 (Dietary Supplement)
Nourished + Yogurt Pregnant Women
Pregnant women who are healthy and selected to receive Moringa and Lactobacillus rhamnosus GR-1 probiotic yogurt. Yogurt contained 4.3 grams of Moringa and 10^8 CFU/mL of Lactobacillus rhamnosus GR-1 as well as Streptococcus thermophilus and Lactobacillus bulgaricus starter cultures.
干预措施: Moringa and Lactobacillus rhamnosus GR-1 (Dietary Supplement)
结局指标
主要结局
Characterization of gut, oral, vaginal and human milk microbiomes
时间窗: Monthly for an average of four months
Fecal, oral and vaginal samples were collected on a monthly basis for an average of four months. Human milk samples were collected twice; at birth and one week after. Microbial DNA will be extracted with the MoBio PowerSoil 96-well htp kit. Samples will be sequenced and changes determined by 16s rRNA profiling.
次要结局
- Analysis of anthropometric measurements(Monthly on average for four months)
- Assessment of 48-hour Dietary Recalls(Monthly on average for four months)
- Changes in body toxin levels(Before and after intervention (approximately 100 days))
- Changes in blood nutrient levels(before, half-way through and after intervention (approximately 100 days))
研究者
Dr. Gregor Reid
Professor
Western University, Canada