A randomised controlled trial of bismuth in the treatment of functional diarrhoea
| ISRCTN | ISRCTN86357226 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86357226 |
| Protocol serial number | N0192080637 |
| Sponsor | Department of Health (UK) |
| Funder | Queen's Medical Centre University Hospital NHS Trust (UK) |
- 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) |
|---|---|
| robin.spiller@nottingham.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Symptom Score (Bowel frequency/day, days of pain/week, presence of urgency, stool consistency), enteroendocrine cell and intraepithelial lymphocyte count on rectal biopsy. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/11/2004 |
| Reason abandoned (if study stopped) | Poor recruitment and lack of staff |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Division of Gastroenterology
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
