Probiotic VSL#3 as a treatment for food intolerant irritable bowel syndrome (IBS)

ISRCTN ISRCTN72387688
DOI https://doi.org/10.1186/ISRCTN72387688
Secondary identifying numbers N0544129304
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
19/07/2017
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

Prof John O Hunter
Scientific

Box No 262
Dept of Gastroenterology
Addenbrooke's NHS Trust
Hills Road
Cambridge
CB2 2QQ
United Kingdom

Phone +44 (0)1223 217469
Email john.hunter@addenbrookes.nhs.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleProbiotic VSL#3 as a treatment for food intolerant irritable bowel syndrome (IBS)
Study objectivesProbiotic VSL#3 as a treatment for food intolerant irritable bowel syndrome.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedIrritable bowel syndrome (IBS)
InterventionPatients with suspected food intolerant IBS will be randomised to receive either VSL#3, a probiotic containing 8 non-pathogenic strains of bacteria or a placebo. The dose of either the VSL#3 or the placebo is dependent on the number of daily bowel movements. The patient will be required to take the full dose of VSL#3 or placebo for 6 weeks. A validated symptom score will used to record symptoms for 2 weeks prior to starting the treatment and for two weeks after one month has elapsed. The validated symptom score will be used to assess if any statistical improvement has occurred in their symptoms. The study will be double-blinded.
Intervention typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date28/03/2003
Completion date27/03/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants20
Key inclusion criteria20 subjects aged 18 - 65 years, either sex
Key exclusion criteriaNot provided at time of registration
Date of first enrolment28/03/2003
Date of final enrolment27/03/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Cambridge Consortium - Addenbrooke's (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

19/07/2017: No publications found, study status unverified.