Contact information
Type
Scientific
Primary contact
Prof John O Hunter
ORCID ID
Contact details
Box No 262
Dept of Gastroenterology
Addenbrooke's NHS Trust
Hills Road
Cambridge
CB2 2QQ
United Kingdom
+44 (0)1223 217469
john.hunter@addenbrookes.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0544129304
Study information
Scientific title
Probiotic VSL#3 as a treatment for food intolerant irritable bowel syndrome (IBS)
Acronym
Study hypothesis
Probiotic VSL#3 as a treatment for food intolerant irritable bowel syndrome.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Irritable bowel syndrome (IBS)
Intervention
Patients 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 type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
28/03/2003
Overall trial end date
27/03/2006
Reason abandoned
Eligibility
Participant inclusion criteria
20 subjects aged 18 - 65 years, either sex
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
28/03/2003
Recruitment end date
27/03/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Cambridge Consortium - Addenbrooke's (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