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

ISRCTN	ISRCTN31320381
DOI	https://doi.org/10.1186/ISRCTN31320381
Secondary identifying numbers	080609/02; KCH1636

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

Dr Guy Sisson
Scientific

Department of Gastroenterology
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom

Phone	+44 (0)20 3299 8773
Email	guy.sisson@kch.nhs.uk

Study design	Randomised controlled trial
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

Participant type(s)	Patient
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

King's College Hospital

London
SE5 9RS
United Kingdom

Kings College Hospital NHS Foundation Trust (UK)
Hospital/treatment centre

Kings College Hospital
Denmark Hill
London
SE5 9RS
England
United Kingdom

Other

Investigator initiated and funded (UK)

No information available

Intention to publish date
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

11/04/2017: No publications found, verifying study status with principal investigator.