Irritable Bowel Syndrome (IBS) Digestive System Irritable bowel syndrome
Conditions
Interventions
25 patients per treatment arm are sufficient to characterise the distribution of outcome variables which may be investigated in the definitive study. Randomisation will continue until a total of 50 ev
Sponsors
Swansea Bay University Health Board
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| IBS severity measured using the IBS severity scoring system questionnaire (IBS-SSS) at baseline (clinic visit 1), 2 weeks after initiation and 4 weeks after initiation Measured at the initial study visit, week 2 post-initiation, week 4 post-initiation and at the final clinic visit at 6 weeks post-initiation: 1. Severity of abdominal pain measured using the IBS-SSS 2. Frequency of abdominal pain measured using the IBS-SSS 3. Abdominal bloating measured using the IBS-SSS 4. Bowel habit "satisfaction" measured using the IBS-SSS 5. Impact of IBS upon lifestyle measured using the IBS-SSS 6. Bowel frequency measured using the IBS-SSS 7. Stool consistency measured using the IBS-SSS 8. Absence from work days related to IBS measured using the IBS-SSS 9. Quality of life measured using the IBS quality of life questionnaire (IBS QOL) | — |
Countries
United Kingdom
Outcome results
None listed