ISRCTN14003582终止Unknown
Pilot study to assess the effect of enzyme-rich malt extract (Juvia) in the treatment of irritable bowel syndrome
Ateria Health Ltd0 个研究点目标入组 9 人开始时间: 2023年5月10日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 终止
- 发起方
- 入组人数
- 9
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 years
- •2. Current symptoms of IBS (abdominal pain and altered bowel habit) ROME IV criteria
- •3. Prepared to take ERME (JUVIA) for the duration (taste test available for the patient)
- •4. Normal full blood count within the last 12 months (from medical notes if available)
- •5. Previous calprotectin (from medical notes if available) <80.ug/g
- •6. Previous tissue transglutaminase (tTG) (from medical notes if available)
- •7. Positive for malfermentation as decided by IBS Questionnaire Score
- •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 that 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 the discretion of the CI)
- •5. Antibiotics in the previous 6 weeks
- •6. Other gastrointestinal disease (e.g. coeliac, Crohn’s disease or Ulcerative colitis )
- •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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