Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0263128752
Study information
Scientific title
Acronym
Study hypothesis
To determine whether polyethylene glycol laxative is superior to fibre supplementation in relieving constipation and improving colonic transit in patients with distal ulcerative colitis
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. Fibre supplementation
2. Polyethylene glycol laxative
Intervention type
Supplement
Phase
Not Specified
Drug names
fibre supplementation vs polyethylene glycol laxative
Primary outcome measures
Assessment of improvement in colonic transit by radioopaque markers study at the end of 4 weeks of treatment
Secondary outcome measures
Not provided at time of registration
Overall trial start date
12/08/2003
Overall trial end date
01/12/2006
Reason abandoned
Eligibility
Participant inclusion criteria
146 patients from Gastroenterology
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
146
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
12/08/2003
Recruitment end date
01/12/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Gastroenterology
London
W1N 8AA
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
University College London 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