IBS with diarrhoea as the predominant symptom (IBS-D) Digestive System Diarrhoea-predominant irritable bowel syndrome
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of diarrhoea-predominant IBS (as per Rome IV criteria) 2. Aged 18-99 years 3. No major co-morbidity 4. IBS-SSS score of >150 5. No evidence of inflammatory bowel disease/microscopic colitis or abdominal surgery (other than appendicectomy) 6. Able to give informed consent. 7. Be able to quantify previous treatments 8. Confirmed stable diet for duration of the study
Exclusion criteria
Exclusion criteria: 1. Prior abdominal surgery other than appendectomy and cholecystectomy. The investigator will clinically exclude bile salt malabsorption. 2. Participating in another trial 3. Pregnant or breast feeding 4. Unwilling to maintain stable doses of IBS therapy (anti-muscarinics, anti-diarrhoeals, anti-depressants) 5. Unwilling to maintain stable diet for the duration of the trial 6. Being in the opinion of the investigator unsuitable 7. Insufficient knowledge of English to complete the questionnaire/diary 8. Hypersensitivity to any component of the supplement 9. Drug interactions with any component of the supplement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in IBS symptom severity score (IBS-SSS) assessed by questionnaire on day 0 and day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Bowel movement frequency assessed using the bowel diary over 28 days 2. Stool consistency assessed using the bowel diary over 28 days 3. Number of days without abdominal pain assessed using the bowel diary over 28 days | — |
Countries
United Kingdom