Irritable bowel syndrome (IBS) Digestive System Irritable bowel syndrome
Conditions
Interventions
Participants will be asked to take two tablespoons of JUVIA (enzyme-rich malt extract) each day for 4 weeks and complete a number of questionnaires and provide samples for biochemical analysis.
Sponsors
Ateria Health Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IBS severity measured using IBS severity score questionnaire from baseline (visit 1) to 4 weeks (visit 2) | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at baseline, 2 and 4 weeks: 1. Severity of abdominal pain measured using IBS patient severity score questionnaire 2. Frequency of abdominal pain measured using IBS patient severity score questionnaire 3. Change in abdominal bloating measured using IBS patient severity score questionnaire 4. Change in bowel habit “satisfaction” measured using IBS patient severity score questionnaire 5. Change in the impact of IBS on lifestyle measured using IBS-OOL questionnaire – validated 6. Change in bowel frequency measured using IBS severity score 7. Change in stool consistency measured using IBS severity score 8. Change in absence from work days related to IBS (as defined by IBS severity score scales) measured using IBS severity score questionnaire 9. Change in IBS quality of life (QoL) questionnaire scores measured using LIFE measures IBS-QOL questionnaire Safety Endpoints: The incidence, nature, severity, relatedness, duration, outcome, seriousness and expectedness of treatment-emergent adverse events, measured by patient reporting during the study at any timepoint Missing Data: Subjects with missing efficacy data will be analysed on a last-observation-carried-forward basis | — |
Countries
United Kingdom, Wales
Outcome results
None listed