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临床试验/NCT03141268
NCT03141268Unknown不适用

Orocecal Transit Time and Fermentation in IBS

Uppsala University1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,000
试验地点
1
主要终点
Orocecal transit time

研究概览

简要总结

Orocecal transit time is studied in individuals with irritable bowel syndrome (IBS) of both the constipation-dominant, diarrhea-dominant, and mixed form using the lactulose hydrogen breath test for orocecal transit time through the gut. Data are compared to those of healthy volunteers. The peak value of fermentation as read by hydrogen levels is captured after passage of the orocecal segment in the colon. Comparison are made between IBS patients and healthy subjects as regards orocecal transit time and peak fermentation in the cecum.

详细描述

Patients with IBS of various kind (constipation-dominant, diarrhea-dominant, and mixed form) in large numbers are studied as regards orocecal transit time and compared to healthy controls.

Inclusion criteria: IBS patients 18-80 years old, diagnosis of IBS; exclusion: Severe cardiac, pulmonary, liver or kidney disease, bloody stool After fasting for 12 hours, all subjects ingest 10 grams of lactulose. Hydrogen production, measured as hydrogen concentration in breath, is estimated at 10-minute intervals for a period of 240 minutes. The orocecal transit transit time is measured from ingestion of the lactulose solution until hydrogen peaks to 10 and 20 ppm when passing the ileocecal valve, being fermented by the cecal microflora. Data are compared to those of healthy volunteers.

The peak value of fermentation as read by hydrogen levels (ppm) captured after passage of the ilecocecal valve orocecal valve signifies the gas production of the micro13flora. Comparison are made between IBS patients and healthy subjects as regards orocecal transit time and peak fermentation in the cecum.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy subjects, or IBS patients or either kind (IBS-C, IBS-D, IBS-M), no concomitant medication.

排除标准

  • Chronic disease, such cardiac, pulmonary, liver, kidney, endocrinological rheumatological, neurological or psychiatric disease plus, in addition, chronic medication.

结局指标

主要结局

Orocecal transit time

时间窗: 0-240 minutes

The transit rate of lactulose (foods) through the small intestine

次要结局

  • Fermentation of lactulose of the cecal microbiota measured as increase of hydrogen in exhaled breath.(0-240 minutes)

研究者

发起方
Uppsala University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Per Hellström

Professor

Uppsala University

研究点 (1)

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