Probiotic VSL#3 as a treatment for food intolerant irritable bowel syndrome (IBS)
| ISRCTN | ISRCTN72387688 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72387688 |
| Protocol serial number | N0544129304 |
| Sponsor | Department of Health |
| Funder | Cambridge Consortium - Addenbrooke's (UK) |
- 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
Scientific
Box No 262
Dept of Gastroenterology
Addenbrooke's NHS Trust
Hills Road
Cambridge
CB2 2QQ
United Kingdom
| Phone | +44 (0)1223 217469 |
|---|---|
| john.hunter@addenbrookes.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 27/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
19/07/2017: No publications found, study status unverified.
