Condition category
Digestive System
Date applied
28/06/2010
Date assigned
05/08/2010
Last edited
28/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Guy Sisson

ORCID ID

Contact details

Department of Gastroenterology
Kings 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 (REC), 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 below 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

Department of Gastroenterology
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

http://www.kch.nhs.uk/

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

Publication citations

Additional files

Editorial Notes