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 |
| Secondary identifying numbers | N0263128752 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 08/04/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
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
Contact information
Dr S L Bloom
Scientific
Scientific
Gastroenterology
G.I. Unit, 2nd Floor
The Middlesex Hospital
Mortimer Street
London
W1N 8AA
United Kingdom
| Phone | +44 (0)20 7380 9126 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 | 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 study start date | 12/08/2003 |
| Completion date | 01/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Gastroenterology
London
W1N 8AA
United Kingdom
W1N 8AA
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
University College London Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
