Condition category
Digestive System
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
28/04/2015
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

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

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

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

Publication citations

Additional files

Editorial Notes