A randomised controlled trial of bismuth in the treatment of functional diarrhoea
ISRCTN | ISRCTN86357226 |
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DOI | https://doi.org/10.1186/ISRCTN86357226 |
Secondary identifying numbers | N0192080637 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 27/09/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- 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
Prof Robin Spiller
Scientific
Scientific
Division of Gastroenterology
C Floor South Block
University Hospital
Nottingham
NG7 2UH
United Kingdom
Phone | +44 (0)115 924 9924 (41352) |
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robin.spiller@nottingham.ac.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
Scientific title | |
Study objectives | Can treatment with bismuth salts improve symptoms in subjects with functional diarrhoea and enteroendocrine cell hyperplasia? |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Digestive System: Diarrhoea |
Intervention | 1. Bismuth treatment group 2. Placebo Added July 2008: trial never started, due to poor recruitment and lack of resources. |
Intervention type | Other |
Primary outcome measure | Symptom Score (Bowel frequency/day, days of pain/week, presence of urgency, stool consistency), enteroendocrine cell and intraepithelial lymphocyte count on rectal biopsy. |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 13/09/1999 |
Completion date | 30/11/2004 |
Reason abandoned (if study stopped) | Poor recruitment and lack of staff |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Upper age limit | 80 Years |
Sex | Both |
Target number of participants | 15 patients with functional diarrhoea, 15 control patients, total=30. |
Key inclusion criteria | 1. Age range of subjects: patients = 18-80 years; control patients 18-80 years 2. Sex of subjects: patients = both; control patients = both |
Key exclusion criteria | Not provided at time of registration |
Date of first enrolment | 13/09/1999 |
Date of final enrolment | 30/11/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Division of Gastroenterology
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Website | http://www.doh.gov.uk |
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Funders
Funder type
Government
Queen's Medical Centre University Hospital NHS Trust (UK)
No information available
Results and Publications
Intention to publish date | |
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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 |