Pilot study to assess the effect of an enzyme-rich malt extract in the treatment of irritable bowel syndrome

Swansea Bay University Health Board0 个研究点目标入组 50 人开始时间: 2021年6月15日最近更新: 2021年7月21日

适应症

试验速览

暂无简介。

•1. Aged 18-65 years
•2. Current symptoms of IBS (abdominal pain and altered bowel habit) ROME IV
•3. Prepared to take ERME for the duration of the study (taste test available for the patient)
•4. Normal full blood count (FBC) within the last 12 months. Due to the disruption caused by COVID-19, if the most recent FBC has expired, patients will be offered a repeat blood test to be performed in the research unit in order to satisfy the inclusion criteria. In the event of an abnormal test, this will be followed up by the referring Gastroenterologist. The sponsor will be covering the costs.
•5. Normal calprotectin within last 12 months <50. Due to the disruption caused by COVID-19, if the faecal calprotectin has expired, patients will be offered a repeat test to be performed in the research unit in order to satisfy the inclusion criteria. In the event of an abnormal test, this will be followed up by the referring Gastroenterologist. The sponsor will be covering the costs.
•6. Normal tTG (Tissue Transglutaminase) <10
•7. Positive IBS subtype malfermentation” confirmed by screening questionnaire 2
•8. Registered with a GP and consent to GP being informed

•1. Pregnant, planning to become pregnant or lactating
•2. Diabetic (or other co-morbidity which the chief/principal investigator 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 chief investigator)
•5. Antibiotic treatment 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

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