Contact information
Type
Scientific
Primary contact
Dr Guy Sisson
ORCID ID
Contact details
Department of Gastroenterology
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
+44 (0)20 3299 8773
guy.sisson@kch.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
080609/02; KCH1636
Study information
Scientific title
Assessment of a multistrain probiotic (symprove) as a dietary supplement in patients with inflammatory bowel disease who are in 'clinical' remission
Acronym
Study hypothesis
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
Outer South East London Research Ethics Committee, 01/10/2009, ref: 09/H0805/37
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Phase II
Drug names
Symprove
Primary outcome measures
Improvement in Inflammatory Bowel Disease Questionnaire (IBDQ) score at week 4
Secondary outcome measures
Reduction in faecal calprotectin at week 4
Overall trial start date
01/07/2010
Overall trial end date
01/07/2011
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
160 (80 each with ulcerative colitis and Crohn's disease)
Participant 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
Recruitment start date
01/07/2010
Recruitment end date
01/07/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
King's College Hospital
London
SE5 9RS
United Kingdom
Sponsor information
Organisation
Kings College Hospital NHS Foundation Trust (UK)
Sponsor details
Kings College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
+44 (0)20 3299 1986
jamie.peterson@nhs.net
Sponsor type
Government
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary