NCT03177681撤回不适用
The Effect of Yogurt in Cancer Patient With Moderate Gastrointestinal (GI) Symptoms
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Percentage Change in Bacteroidetes in Stool from Baseline to Day 12
研究概览
简要总结
The goal of this clinical research study is to learn if probiotics found in yogurt can help to decrease gastrointestinal (GI) symptoms in cancer patients. Probiotics are live bacteria and yeast that help with many of our functions and may help digestive problems. Researchers also want to learn if the bacteria in your stool change as your symptoms change while eating yogurt.
详细描述
Baseline Tests:
If you agree to take part in this study, you will have the following tests and procedures when you enroll:
- The coating on your tongue will be checked. Researchers think that the thickness of the coating on your tongue may be related to the microorganisms in your stomach and/or intestines.
- A stool sample will be collected for bacteria testing.
- You will be asked about your diet and how often you eat yogurt.
- You will wear a monitoring device called a Holter monitor for 20-24 hours to check your nervous system and heart function.
- You will be asked to complete 4 questionnaires about your symptoms in the past 24 hours, your irritable bowel syndrome (IBS), your most recent stool, and your quality-of-life. These questionnaires should take about 30 minutes total to complete.
Study Procedures:
One (1) time during Days 3-7 and 1 time during Days 8-12:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cancer patient
- •18 years old or older
- •Has gastrointestinal symptoms with severity score of </= 60 out of 100 visual analog scale for irritable bowel syndrome (VAS-IBS) in at least 2 out of 7 items measured
- •Able to eat by mouth
- •Estimated length of hospital stay is 10 days or more
- •Must give written study consent
排除标准
- •Neutropenic patient with absolute neutrophil count (ANC) less than 1000 cells/mm3
- •Patient within 100 days of auto /allo stem cell transplant and their stem cell physician does not approve yogurt ingestion.
- •Has intestinal obstruction.
- •Patient is currently on antibiotics
- •Allergic to yogurt
- •Patient who eats yogurt equal or more than once a day in the last 3 days.
结局指标
主要结局
Percentage Change in Bacteroidetes in Stool from Baseline to Day 12
时间窗: Baseline to Day 12
Percentage Change in Firmicutes in Stool from Baseline to Day 12
时间窗: Baseline to Day 12
次要结局
- Adherence Rate of Dannon® Oikos® Yogurt Intake(12 days)
研究者
研究点 (2)
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