EUCTR2015-005467-16-NL进行中(未招募)1 期
Peppermint oil for the treatment of Irritable Bowel Syndrome: optimizing therapeutic strategies using targeted delivery - PERSUADE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 178
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age between 18 and 75 years;
- •2. Diagnosed with Irritable Bowel Syndrome according to the Rome III criteria:
- •Recurrent abdominal pain or discomfort, at least 3 days/month for the last 3 months;
- •Symptom onset at least 6 months prior to diagnosis
- •Associated with two or more of the following:
- •1. Improvement with defecation;
- •2. Onset associated with a change in frequency of stool;
- •3. Onset associated with a change in form (appearance/consistency) of stool;
- •3. Based on the medical history and previous examination, no other causes for the abdominal complaints can be defined. Especially no history of:
- •a. Inflammatory Bowel Disease;
- •b. Celiac Disease;
- •c. Thyroid dysfunction (if not well-regulated);
- •If alarm symptoms (including unexplained rectal blood loss or weight loss) are present, a colonoscopy has been performed and was negative for other causes.
- •4. Women in fertile age (<55 years old) must use contraception or be postmenopausal for at least two years.
- •5. Average worst abdominal pain score (on 11-point NRS) of > 3, during the two-week run-in period.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 38
排除标准
- •1. Insufficient fluency of the Dutch language;
- •2. Any previous use (also incidental use) of peppermint oil capsules in the last 3 months prior to inclusion;
- •3. The inability to stop regular use of medication affecting the gastro-intestinal system (such as Non Steroidal Anti Inflammatory Drugs (NSAID), laxatives, prokinetics, opioids, smasmolytics and anti-diarrhoeal drugs);
- •a. The use of 1 antidepressant drug is allowed, providing dosing has been stable for > 6 weeks before enrollment;
- •b. The use of 1 proton pump inhibitors (PPI) is allowed, providing dosing has been stable > 6 weeks before enrollment;
- •4. Previous major abdominal surgery or radiotherapy interfering with gastrointestinal function:
- •a. Uncomplicated appendectomy, cholecystectomy and hysterectomy allowed unless within the past 6 months;
- •b. Other surgery upon judgment of the principle investigator;
- •5. History of liver disease, cholangitis, achlorhydria, gallstones or other diseases of the gallbladder/biliary system;
- •6. Pregnancy, lactation;
- •7. Using drugs of abuse;
- •8. Known allergic reaction to peppermint.
研究者
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