A Study of the Effect of Probiotics on Gastrointestinal Function During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Number of vomiting and nausea per day
研究概览
简要总结
The purpose as well as the aim of this project is to understand the effect of probiotics on gastrointestinal (GI) dysfunction such as nausea, vomiting, and constipation that are found during the first and second trimesters of pregnancy.
The primary objective of this project is to uncover whether probiotics have an effect on GI functional disorders.
The secondary objective is to identify the microbiota associated with probiotic intake.
The tested hypothesis is that gut microbiota influences the GI functions and may influence constipation, nausea, and vomiting during pregnancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •First and second trimester healthy or low risk pregnant women who report gastrointestinal disorders such as nausea, vomiting, and constipation
- •Definition of healthy or low risk pregnant women:
- •Systolic blood pressure < 140 mmHg and diastolic blood pressure < 90 mmHg
- •Hemoglobin ≥ 10.0 g/dL
- •Have immunity against rubella (German measles)
- •HIV negative
- •Urine test shows no sign of kidney or urinary tract infection
- •27 weeks 6 days gestation or less with confirmed fetal heart beat
- •Pregnant women age 18 and older
排除标准
- •High risk pregnant women who have existing health conditions such as high blood pressure, Type 1 diabetes, HIV positive, or are infected with Hepatitis B, Syphilis, or other sexually transmitted diseases
- •Pregnant women who have multiple gestations or a history of recurrent miscarriages (more than two consecutive miscarriages)
- •Had prior bariatric surgery
- •Conceived through IVF program
- •Pregnant women who have had severe weight loss (more than 5 pounds) during pregnancy. [Note: Mild weight loss (2-3 pounds) due to nausea, vomiting, or loss of appetite is considered normal.]
- •Medical history of irritable bowel syndrome or other non-pregnancy related GI dysfunction/disorder
研究组 & 干预措施
Probiotic 10 (Nature's Bounty)
The suggested dose will be two (2) pills of Probiotic 10 (Nature's Bounty) after dinner daily. Subjects will be asked to take probiotics for six (6) days after providing baseline fecal specimen. Subjects will self-report their daily GI function including the frequency of nausea, vomiting, and bowel movement(s). Then, the subjects will stop taking probiotics for two (2) days and resume taking probiotics for another six (6) days. This six (6)-day on and two (2)- day off cycle is repeated two (2) times.
干预措施: Probiotic 10 (Nature's Bounty) (Dietary Supplement)
结局指标
主要结局
Number of vomiting and nausea per day
时间窗: 16 days following baseline fecal sample collection
Using scale of 1-5, quantify the seriousness of sick to the stomach, dry heaves, fatigue, lack of energy, and feeling blue.
次要结局
- The relative quantity of gut bacteria at phylum, family, and species level when patients take or do not take Probiotic-10.(16 days following baseline fecal sample collection)