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
Protocol serial number	N0176127663
Sponsor	Department of Health
Funder	Oxford Radcliffe Hospitals NHS Trust (UK)

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 Derek P Jewell
Scientific

Gastroenterology Lab
Gibson Building
Radcliffe Infirmary
Woodstock Road
Oxford
OX2 6HE
United Kingdom

Phone	+44 (0)1865 224829
Email	derek.jewell@ndm.ox.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Probiotoc preparations
Primary outcome measure(s)	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.)
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2004
Reason abandoned (if study stopped)	No patient enrolled.

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	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

Gastroenterology Lab

Oxford
OX2 6HE
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan