A one year, randomised, double blind, placebo controlled trial of probiotics. Bifidobacterium infantis 35624 or Lactobacillus salivarious UCC118, as food supplements for maintenance of remission in Ulcerative colitis.
| ISRCTN | ISRCTN11348435 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11348435 |
| Secondary identifying numbers | N0176127663 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 27/09/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- 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 Derek P Jewell
Scientific
Scientific
Gastroenterology Lab
Gibson Building
Radcliffe Infirmary
Woodstock Road
Oxford
OX2 6HE
United Kingdom
| Phone | +44 (0)1865 224829 |
|---|---|
| derek.jewell@ndm.ox.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | The primary aim of the study is to determine whether ingestion of probiotic preparations (containing Lactobacillus salivarious subsp. Salivarious UCC118 or Bifidobacterium infantis 35624) can help in the maintenance of remission of patients with ulcerative colitis over a period of one year (i.e. delay the onset of relapse). Secondary aims include an evaluation of the immunological and biochemical parameters of the immuno-inflammatory response and an assessment of the faecal flora in patients consuming the probiotic and control products. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Digestive System: Ulcerative colitis |
| Intervention | 1. Bifidobacterium infantis 35624 2. Lactobacillus salivarious UCC118 3. Placebo July 2008: no patients enrolled in this trial. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Probiotoc preparations |
| Primary outcome measure | A failure to maintain remission over a period of 1 year. Using the simple ulcerative colitis activity index, a score of >- 7 indicates relapse. (i.e. Relapse - CAIA >- 7 and/or a requirement for clinical intervention e.g. drugs/surgery etc.) |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/10/2001 |
| Completion date | 31/12/2004 |
| Reason abandoned (if study stopped) | No patient enrolled. |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 180 |
| Key inclusion criteria | 120 patients, 60 control patients. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/10/2001 |
| Date of final enrolment | 31/12/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Gastroenterology Lab
Oxford
OX2 6HE
United Kingdom
OX2 6HE
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Oxford Radcliffe Hospitals NHS Trust (UK)
No information available
Results and Publications
| 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 |
