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

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

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 design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Probiotic VSL#3 as a treatment for food intolerant irritable bowel syndrome (IBS)
Study objectives	Probiotic 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) studied	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
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	28/03/2003
Completion date	27/03/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	20
Key inclusion criteria	20 subjects aged 18 - 65 years, either sex
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	28/03/2003
Date of final enrolment	27/03/2006

Addenbrooke's NHS Trust

Cambridge
CB2 2QQ
United Kingdom

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

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

Government

Cambridge Consortium - Addenbrooke's (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

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