Effect of enzyme rich malt extract (erme) in treatment of Irritable Bowel Syndrome (IBS)

Not Applicable

Completed

• Conditions: Irritable Bowel Disease; Digestive System; Irritable bowel syndrome

• Registration Number: ISRCTN21365636
• Lead Sponsor: York Teaching Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-14
• Study Completion: 2018-12-31
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IBS severity is measured using the IBS Severity Score Questionnaire at 6 weeks