Can an enzyme-rich malt extract improve the symptoms of irritable bowel syndrome?

Not Applicable

• Conditions: Irritable Bowel Syndrome (IBS); Digestive System; Irritable bowel syndrome

• Registration Number: ISRCTN14173715
• Lead Sponsor: Swansea Bay University Health Board

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-15
• Last Update Posted: 21 July 2021
• Study Completion: 2022-08-01

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IBS severity measured using the IBS severity scoring system questionnaire (IBS-SSS) at the initial clinic visit and at the final clinic visit 6 weeks after initiation