Inflammatory bowel disease (ulcerative colitis and Crohn's disease) Digestive System Inflammatory bowel disease
Conditions
Interventions
160 patients with mild/moderate IBD will be randomly assigned (1:1 UC and 1:1 Crohn's disease) to receive 1 ml/kg/day (max 100 ml) of probiotic or placebo for 4 weeks.
Sponsors
Kings College Hospital NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 - 65 years, either sex 2. Minimum 6 months history of inflammatory bowel disease 3. Confirmed both endoscopically and histologically 4. Three months of 'stable clinical remission' - including no change in treatment during the preceding 3 months
Exclusion criteria
Exclusion criteria: 1. Aged less than 16 years and greater than 65 years 2. Severe disease or current disease flare 3. Current use of biological or immunosupressive treatments (including infliximab, adalimumab, methotrexate, azathioprine, 6-mercaptopurine, cyclosporin). Patients who are taking azathioprine or 6-mercaptopurine who have been stable on treatment for a minimum of 12 weeks without major side effects or adverse events will not be excluded. 4. Previous complicated bowel resections or multiple bowel resections 5. Pregnancy or actively seeking pregnancy 6. History of intolerance or allergy to probiotics 7. Significant comorbid conditions (to be judged by the research doctor at assessment) 8. Significant psychiatric comorbidity (to be judged by the research doctor at assessment) 9. Current drug or alcohol dependence syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in Inflammatory Bowel Disease Questionnaire (IBDQ) score at week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in faecal calprotectin at week 4 | — |
Countries
United Kingdom
Outcome results
None listed