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

Double blind randomised controlled trial comparing the effect of enzyme rich malt extract with placebo in the treatment of irritable bowel syndrome

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN21365636

Enrollment

110

Registered

2017-12-14

Start date

2018-01-03

Completion date

Unknown

Last updated

2021-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Disease Digestive System Irritable bowel syndrome

Interventions

Participants will be randomised 1:1 to either ERME (enzyme rich malt extract) or control (heat denatured malt product). Participants will be asked to consume 30 ml per day for 6 weeks. Participants wi

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
IBS severity is measured using the IBS Severity Score Questionnaire at 6 weeks	—

Secondary

Measure	Time frame
1. Severity of abdominal pain is measured using IBS Severity Score Questionnaire at baseline, 2,4, 6 and 8 weeks 2. Frequency of abdominal pain is measured using IBS Severity Score Questionnaire at baseline, 2,4, 6 and 8 weeks 3. Abdominal bloating measured using IBS Severity Score Questionnaire at baseline, 2,4, 6 and 8 weeks 4. Bowel habit “satisfaction” is measured using IBS QoL Questionnaire at baseline 2,4, 6 and 8 weeks 5. impact of IBS upon lifestyle is measured using IBS QoL Questionnaire at baseline, 2,4, 6 and 8 weeks 6. Bowel frequency is measured using self-report by participants at baseline and 6 weeks 7. Stool Consistency is measured using Bristol Stool Chart at baseline and 6 weeks 8. Absence from work days related to IBS is measured using IBS Severity score scales at baseline , 2,4, 6 and 8 weeks 9. IBS quality of life is measured using IBS QoL Questionnaire Score at baseline , 2,4, 6 and 8 weeks	—

Measure

Time frame

1. Severity of abdominal pain is measured using IBS Severity Score Questionnaire at baseline, 2,4, 6 and 8 weeks 2. Frequency of abdominal pain is measured using IBS Severity Score Questionnaire at baseline, 2,4, 6 and 8 weeks 3. Abdominal bloating measured using IBS Severity Score Questionnaire at baseline, 2,4, 6 and 8 weeks 4. Bowel habit “satisfaction” is measured using IBS QoL Questionnaire at baseline 2,4, 6 and 8 weeks 5. impact of IBS upon lifestyle is measured using IBS QoL Questionnaire at baseline, 2,4, 6 and 8 weeks 6. Bowel frequency is measured using self-report by participants at baseline and 6 weeks 7. Stool Consistency is measured using Bristol Stool Chart at baseline and 6 weeks 8. Absence from work days related to IBS is measured using IBS Severity score scales at baseline , 2,4, 6 and 8 weeks 9. IBS quality of life is measured using IBS QoL Questionnaire Score at baseline , 2,4, 6 and 8 weeks

—

Countries

United Kingdom

Contacts

Public ContactTracey Dorey

tracey.dorey@york.nhs.uk+44 (0)1904 726954

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026