Serine Proteases in Gastrointestinal Function and Irritable Bowel Syndrome (IBS)
关键词
抽象
日期
| 最后验证: | 03/31/2014 |
| 首次提交: | 02/17/2010 |
| 提交的预估入学人数: | 02/18/2010 |
| 首次发布: | 02/21/2010 |
| 上次提交的更新: | 03/09/2016 |
| 最近更新发布: | 03/10/2016 |
| 实际学习开始日期: | 01/31/2009 |
| 预计主要完成日期: | 11/30/2015 |
| 预计完成日期: | 11/30/2015 |
状况或疾病
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| IBS Subjects with IBS-D | |
| Healthy Healthy Subjects |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 取样方式 | Non-Probability Sample |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Any sex, race, or ethnicity. - At least 18 years of age (no upper age limit). - D-IBS patients must meet Rome III criteria for IBS and must have been evaluated by a physician to exclude other diseases that could explain the symptoms. For the latter, patients self statement is acceptable (no official document is required). - Participation in Dr. Whitehead's 'heterogeneity of IBS' and/or Dr. Ringel's 'intestinal inflammation in patients with D-IBS' research study. Exclusion Criteria: - Healthy controls must have no significant or recurring gastrointestinal symptoms. - Patients and healthy controls should not have a serious, unstable medical condition. - Patients and healthy controls must have had no gastrointestinal tract surgery other than appendectomy or cholecystectomy. - Patients and healthy controls must not be pregnant (by self-report). Pregnant women will not be allowed to participate as pregnancy can affect gastrointestinal symptoms. - Patients and healthy controls must not have a history of inflammatory bowel disease, celiac disease, or other diagnosis that could explain chronic or recurring bowel symptoms in IBS patients or controls. - Patients and healthy controls should have no history of lactose malabsorption (by self-report). - Patients and healthy controls should have no history of clinical symptoms of acute infections during the last 8 weeks prior to enrolment in the study. - Patients and healthy controls should have no history of anti-inflammatory agents including aspirin, non-aspirin, non-steroid anti-inflammatory (NSAID) or steroids in the last four weeks prior to study enrollment. - Patients should not intentionally consume probiotics or undergo antibiotic treatment during the last 4 weeks prior to enrolment in the study. If the subject consumed any of these medications, a washout period of 4 weeks will be required). - Patients must have no history of fainting or light headedness during periods of fasting. - Patients must not have diabetes mellitus, or any similar conditions, that would cause an adverse reaction to the sugar drink. |
结果
主要结果指标
1. fecal serine protease activity [protease activity determined at at recruitment]
次要成果指标
1. intestinal permeability [6hrs following recruitment]
