Elucidating the Influence of Lactulose Intake on the Gut Microbiota Composition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Influence of lactulose intake on gut microbiota composition (microbiota sequencing, analysis of E. coli)
研究概览
简要总结
This study will test the influence of lactulose of the human gut microbiota. Healthy volunteers will ingest 50g of lactulose and donate stool samples 1 day before as well as 1-2 days and 14 days after the test. Using sequencing and metabolomics techniques the investigators will identify changes in microbiota composition upon lactulose exposure.
详细描述
This is a clinical study for investigating the influence of lactulose on the composition and metabolic activities of the intestinal microbiota. We will recruit 40 healthy volunteers. Subjects will be randomized and receive either 50g lactose (intervention group) or 50g sucrose (control group).
Subjects will donate fecal samples 24h before and after (1-2d, 14d) lactulose ingestion. After ingestion H2-in expiratory air and symptoms will be followed for 3 hours.
Frozen samples will be analyzed for their microbiota composition and key metabolites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects free of relevant abdominal complaints (=healthy)
- •Written informed consent
- •Working at ETH Zurich/University of Zurich, experience in handling of -80°C freezers on biosafety level 2
排除标准
- •Previous history of gastrointestinal disease or surgery (excludes appendectomy, hernia repair and anorectal disorders)
- •Known diabetes mellitus, scleroderma, neurological impairment or other major current disease
- •Subjects unable to stop medication that alters gut flora: proton pump inhibitors, laxatives and antibiotics at least 4 weeks before study entry.
- •Pregnancy beyond week 12 (no pregnancy test will be performed)
- •Involvement in any other clinical trial during the course of this trial, nor within a period of 14 days prior to its beginning or 14 days after its completion
研究组 & 干预措施
Lactulose group
Subjects will ingest 50g of lactulose once
干预措施: application of lactulose (Drug)
Control group
Subjects will ingest 50g of sucrose once
干预措施: application of sucrose (Other)
结局指标
主要结局
Influence of lactulose intake on gut microbiota composition (microbiota sequencing, analysis of E. coli)
时间窗: 1-2 days after ingestion of lactulose
microbiota sequencing, analysis of E. coli
次要结局
- Influence of lactulose intake on metabolic profiles within the fecal ecoystem (metabolomics analysis)(1-2 days after ingestion of lactulose)
- Correlation of gut microbiota composition and H2-peak (H2-measurements)(within 3 hours after lactulose ingestion)
- Correlation of gut microbiota composition and symptoms (standardized record of symptoms)(within 3 hours after lactulose ingestion)