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
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

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 information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeOther
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleAssessment of a multistrain probiotic (symprove) as a dietary supplement in patients with inflammatory bowel disease who are in 'clinical' remission
Study objectivesRegular 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) studiedInflammatory bowel disease (ulcerative colitis and Crohn's disease)
Intervention160 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 typeDrug
Pharmaceutical study type(s)
PhasePhase II
Drug / device / biological / vaccine name(s)Symprove
Primary outcome measureImprovement in Inflammatory Bowel Disease Questionnaire (IBDQ) score at week 4
Secondary outcome measuresReduction in faecal calprotectin at week 4
Overall study start date01/07/2010
Completion date01/07/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participants160 (80 each with ulcerative colitis and Crohn's disease)
Key inclusion criteria1. 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 criteria1. 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 enrolment01/07/2010
Date of final enrolment01/07/2011

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

King's College Hospital
London
SE5 9RS
United Kingdom

Sponsor information

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

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

Phone +44 (0)20 3299 1986
Email jamie.peterson@nhs.net
Website http://www.kch.nhs.uk/
ROR logo "ROR" https://ror.org/01n0k5m85

Funders

Funder type

Other

Investigator initiated and funded (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

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