Condition category
Digestive System
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
08/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr S L Bloom

ORCID ID

Contact details

Gastroenterology
G.I. Unit
2nd Floor
The Middlesex Hospital
Mortimer Street
London
W1N 8AA
United Kingdom
+44 (0)20 7380 9126

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes