NCT02912416已完成不适用
Efficacy of Probiotics on Iron Status During Pregnancy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Probi AB
- 入组人数
- 326
- 试验地点
- 2
- 主要终点
- Serum ferritin level
研究概览
简要总结
Determine the effect of probiotics on improving iron status in a population of healthy, pregnant women.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Healthy, pregnant women, aged 18-42 years, with a singleton gestation
- •Inclusion at 10-12 weeks of gestation
- •BMI ≥ 18 and ≤ 30 at baseline
- •Provide signed and dated informed consent form
- •Willing to comply with all study procedures
排除标准
- •Serum ferritin level <20 µg/L or Hb<110 g/L at baseline (visit 1)
- •Chronic diseases associated with anemia
- •Known Thalassemia
- •Hyperemesis gravidarum
- •Chronic gastrointestinal disease (inflammable bowel diseases; Crohn's disease, Ulcerative Colitis; diarrheal disease)
- •Known gluten intolerance, lactose intolerance, milk protein allergy
- •Taking antibiotics within four weeks before inclusion
- •Blood or plasma donation within three (3) months prior to baseline
- •History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
- •Smoking or use of nicotine-containing products (currently or during the last three [3] months)
- •History of alcohol abuse, or excessive intake of alcohol, as judged by the Investigator
- •Hypersensitivity to any of the ingredients in the study products
- •Any other reason for exclusion, as judged by the Investigator
结局指标
主要结局
Serum ferritin level
时间窗: Week 28 of gestation
次要结局
未报告次要终点
研究者
研究点 (2)
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