Assessment of a multistrain probiotic in inflammatory bowel disease (IBD)

Phase 2

Completed

• Conditions: Inflammatory bowel disease (ulcerative colitis and Crohn's disease); Digestive System; Inflammatory bowel disease

• Registration Number: ISRCTN31320381
• Lead Sponsor: Kings College Hospital NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-05
• Last Update Posted: 8 May 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 160

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in Inflammatory Bowel Disease Questionnaire (IBDQ) score at week 4

Secondary Outcome Measures

Name	Time	Method
Reduction in faecal calprotectin at week 4