NL-OMON48827已完成不适用
Exploring the role of faecal mesalazine (5-ASA) concentrations in therapeutic drug monitoring in ulcerative colitis: a pilot study. - TDM-5-ASA
Maag, darm, leverziekten0 个研究点目标入组 28 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •In order to participate in this study, a subject must meet all of the following criteria:
- •- Patients >18 year old with established ulcerative colitis in care in the UMC Utrecht
- •- Indication for an endoscopy (diagnostic endoscopy during a flare or regular surveillance endoscopy during clinical remission; colonoscopy or sigmoidoscopy)
- •- Using an oral 5-ASA formulation (except a prodrug) per day for at least two weeks in a dose of 2.0 until 3,0 gram/day during active disease (thus endoscopy for flare) or 2.0 until 4.8 gram/day during remission (endoscopy for surveillance)
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •- Previous intestinal surgery (with the exception of appendectomy)
- •- Need for surgical interventions
- •- Active use of laxatives (bisacodyl, poly ethyleen glycol / Pegol) or anti-diarrheal mediation (opioids, codeine, loperamide)
- •- Combination use with other 5-ASA formulations (enema, suppository)
- •- Pregnancy
- •- Stool frequency less than 1 time a day (slow intestinal transit time)
- •- Uncontrolled or sever liver, renal, cardiac or pulmonary disease:
- •o Liver: Child-Pugh score > 7
- •o Renal: GFR < 60 ml/min for more than 3 months
- •o Pulmonal: COPD GOLD stage 3-4, need of oxygen supply at home, or uncontrolled asthma
- •o Cardiac: heart failure NYHA class 3-4 or myocardial infarct in the past 12 months
研究者
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