Irritable bowel syndrome Digestive System Irritable bowel syndrome
Conditions
Interventions
Symprove probiotic dietary supplement (1 ml/kg) or placebo. Following a 1-week run-in period, all patients will receive 12 weeks of treatment (either placebo or active treatment) followed by a further
Sponsors
Kings College Hospital (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 18 - 65 years, either sex 2. A firm diagnosis of IBS (ROME III criteria) 3. Moderate to severe symptoms
Exclusion criteria
Exclusion criteria: 1. Diagnosis of inflammatory bowel disease or other organic bowel disease 2. Significant co-morbidity 3. Major psychological disorders 4. Previous/current history of alcohol or drug dependence 5. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 22/10/2013: 1. Efficacy ? change in IBS Symptom Severity Score (IBS-SSS) from baseline to week 12 2. Safety ? tolerability of the multistrain probiotic The above change in protocol was made prior to the trial opening Previous primary outcome measures: Improvement in quality of life (QOL) as measured by a validated QOL questionnaire on week 12 of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 22/10/2013: Improvements in symptoms and QoL as described by: 1. Change in IBS-QoL score from baseline to week 12 2. Change in IBS-SSS component scores at week 12 3. Changes in IBS-SSS and QoL between week 12 and 16 The above change in protocol was made prior to the trial opening Previous secondary outcome measures: 1. Improvement in Sleep Quality Assessment 2. Improvement in Global Symptom Severity Score and specific symptom sub-scores (abdominal pain, bloating, stool frequency and stool consistency) These will all be assessed at 4 weekly intervals (4, 8 and 12 weeks of treatment and week 16 - 4 weeks after treatment) | — |
Countries
United Kingdom
Outcome results
None listed