Synbiotic Supplement Effects on Gastrointestinal Symptoms and Gut Microbiota and Fecal Metabolomics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change in microbiome stool diversity
研究概览
简要总结
To test the feasibility and safety of our designer synbiotic on gastrointestinal symptoms and gut microbiota and fecal metabolomics.
详细描述
This will be a double-blinded, randomized, placebo-controlled paired crossover pilot study in healthy controls aimed to evaluate gastrointestinal tolerance of a synbiotic dietary supplement.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 19-25 (lean) and BMI 30-35 (obese)
- •Age 18-45 years old
- •subjects must be willing to consume oral dietary supplement and placebo daily for a total of 56 days,
- •willing to complete gastrointestinal (GI) and dietary surveys, body composition assessment, and provide blood, urine and stool sample at 4 intervals during the pilot study (baseline, after first supplementation period (day 28), after washout period (day 49), and after second supplementation period (day 77)
排除标准
- •antibiotic consumption within 28 days of study initiation
- •kidney disorders
- •history of cardiac disease and medications for cardiac disease
- •use of statins and antihypertensive drugs
- •inflammatory bowel disease
- •irritable bowel syndrome
- •history of small intestinal bacterial overgrowth
- •history of intestinal surgery, excluding hernia repair and appendectomy
- •active cancer diagnosis; chronic acid suppression treatment (proton pump inhibitors, histamine H2 receptor antagonists)
- •immune modulatory treatments (e.g. chronic immunosuppressive medications, chronic NSAIDs)
- •abnormal liver or kidney function as measured by routine serum chemistry testing
- •severe anemia or significant white blood cell or platelet abnormalities
- •no additional blood or blood product donations during study
结局指标
主要结局
Change in microbiome stool diversity
时间窗: Baseline, Day 28, day 49, day 77
Change in metabolome urine profile
时间窗: Baseline, Day 28, day 49, day 77
Measure change in gastrointestinal symptoms using "Rating of Gastrointestinal (GI) Symptoms" scale
时间窗: Baseline, Day 28, day 49, day 77
Rating of GI Symptoms scale includes 5 questions, which range from 0 (never affected) to 7 (always bothered), summed to compute total score
Change in metabolome stool profile
时间窗: Baseline, Day 28, day 49, day 77
次要结局
未报告次要终点
研究者
Gail Cresci
Director Nutrition Research within Center for Human Nutrition
The Cleveland Clinic