Assessment of a multistrain probiotic in inflammatory bowel disease (IBD)
ISRCTN | ISRCTN31320381 |
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DOI | https://doi.org/10.1186/ISRCTN31320381 |
Secondary identifying numbers | 080609/02; KCH1636 |
- Submission date
- 28/06/2010
- Registration date
- 05/08/2010
- Last edited
- 11/04/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Guy Sisson
Scientific
Scientific
Department of Gastroenterology
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
Phone | +44 (0)20 3299 8773 |
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guy.sisson@kch.nhs.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Other |
Study type | Other |
Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
Scientific title | Assessment of a multistrain probiotic (symprove) as a dietary supplement in patients with inflammatory bowel disease who are in 'clinical' remission |
Study objectives | Regular use of this multistrain probiotic may have anti-inflammatory properties and help improve the residual symptoms of inflammatory bowel disease (IBD) experienced by patients in 'clinical remission'. |
Ethics approval(s) | Outer South East London Research Ethics Committee, 01/10/2009, ref: 09/H0805/37 |
Health condition(s) or problem(s) studied | Inflammatory bowel disease (ulcerative colitis and Crohn's disease) |
Intervention | 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. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Phase II |
Drug / device / biological / vaccine name(s) | Symprove |
Primary outcome measure | Improvement in Inflammatory Bowel Disease Questionnaire (IBDQ) score at week 4 |
Secondary outcome measures | Reduction in faecal calprotectin at week 4 |
Overall study start date | 01/07/2010 |
Completion date | 01/07/2011 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Upper age limit | 65 Years |
Sex | Both |
Target number of participants | 160 (80 each with ulcerative colitis and Crohn's disease) |
Key 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 |
Key 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 |
Date of first enrolment | 01/07/2010 |
Date of final enrolment | 01/07/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
King's College Hospital
London
SE5 9RS
United Kingdom
SE5 9RS
United Kingdom
Sponsor information
Kings College Hospital NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Kings College Hospital
Denmark Hill
London
SE5 9RS
England
United Kingdom
Phone | +44 (0)20 3299 1986 |
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jamie.peterson@nhs.net | |
Website | http://www.kch.nhs.uk/ |
https://ror.org/01n0k5m85 |
Funders
Funder type
Other
Investigator initiated and funded (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Editorial Notes
11/04/2017: No publications found, verifying study status with principal investigator.