Constipation in Distal Ulcerative Colitis: A clinico-radiological comparison of the effectiveness of fibre supplementation vs polyethylene glycol laxative

ISRCTN	ISRCTN97214617
DOI	https://doi.org/10.1186/ISRCTN97214617
Protocol serial number	N0263128752
Sponsor	Department of Health
Funder	University College London 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

Dr S L Bloom
Scientific

Gastroenterology
G.I. Unit, 2nd Floor
The Middlesex Hospital
Mortimer Street
London
W1N 8AA
United Kingdom

Phone	+44 (0)20 7380 9126

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Digestive System: Ulcerative colitis
Intervention	1. Fibre supplementation 2. Polyethylene glycol laxative
Intervention type	Supplement
Primary outcome measure(s)	Assessment of improvement in colonic transit by radioopaque markers study at the end of 4 weeks of treatment
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/12/2006

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	146
Key inclusion criteria	146 patients from Gastroenterology
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	12/08/2003
Date of final enrolment	01/12/2006

Gastroenterology

London
W1N 8AA
United Kingdom

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