ISRCTN21365636已完成未知
Double blind randomised controlled trial comparing the effect of enzyme rich malt extract with placebo in the treatment of irritable bowel syndrome
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 18-65
- •2. Current symptoms of IBS (abdominal pain and altered bowel habit) ROME IV
- •3. Prepared to take ERME for duration (taste test available for patient)
- •4. Normal full blood count within last 12 months (from notes)
- •5. Normal calprotectin within last 12 months <50 (from notes)
- •6. Normal tTG (Tissue Transglutaminase) <10 (from notes)
- •7. Positive for malfermentation (from IBS Questionnaire Score) – decision by CI
- •8. Registered with a GP and consent to GP being informed
排除标准
- •1. Pregnant, planning to become pregnant or lactating
- •2. Diabetic (or other co-morbidity which the CI considers inappropriate)
- •3. On a restrictive diet or unwilling or unable to change diet
- •4. Current medication (e.g. opiates) that may influence bowel symptoms (at discretion of the CI)
- •5. Antibiotics in the previous 6 weeks
- •6. Other gastrointestinal disease (e.g. coeliac or Crohn’s disease)
- •7. Significant gastrointestinal surgery (this will be a clinical decision and any patient who has had a surgical procedure that would change the mechanics of gut function would be excluded)
- •8. Involved in other gastroenterology research project or other interventional study that would affect results
研究者
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