Condition category
Digestive System
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
27/09/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Derek P Jewell

ORCID ID

Contact details

Gastroenterology Lab
Gibson Building
Radcliffe Infirmary
Woodstock Road
Oxford
OX2 6HE
United Kingdom
+44 (0)1865 224829
derek.jewell@ndm.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0176127663

Study information

Scientific title

Acronym

Study hypothesis

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

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

Not Specified

Patient information sheet

Condition

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 names

Probiotoc preparations

Primary outcome measures

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 trial start date

01/10/2001

Overall trial end date

31/12/2004

Reason abandoned

No patient enrolled.

Eligibility

Participant inclusion criteria

120 patients, 60 control patients.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

180

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/10/2001

Recruitment end date

31/12/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Gastroenterology Lab
Oxford
OX2 6HE
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

Oxford Radcliffe Hospitals NHS Trust (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