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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 13 January 2015
Main ID:  ISRCTN86357226
Date of registration: 12/09/2003
Prospective Registration: No
Primary sponsor: Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
Public title: A randomised controlled trial of bismuth in the treatment of functional diarrhoea
Scientific title:
Date of first enrolment: 13/09/1999
Target sample size: 30
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN86357226
Study type:  Interventional
Study design:  Randomised controlled trial (Not Specified)  
Phase: 
Countries of recruitment
United Kingdom
Contacts
Name: Robin    Spiller
Address:  Division of Gastroenterology C Floor South Block University Hospital NG7 2UH Nottingham United Kingdom
Telephone: +44 (0)115 924 9924 (41352)
Email: robin.spiller@nottingham.ac.uk
Affiliation: 
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
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

Exclusion criteria: Not provided at time of registration

Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Digestive System: Diarrhoea
Digestive System
Diarrhoea
Intervention(s)
1. Bismuth treatment group
2. Placebo

Added July 2008: trial never started, due to poor recruitment and lack of resources.
Primary Outcome(s)
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(s)
Not provided at time of registration
Secondary ID(s)
N0192080637
Source(s) of Monetary Support
Queen's Medical Centre University Hospital NHS Trust (UK)
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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