Contact information
Type
Scientific
Primary contact
Prof Robin Spiller
ORCID ID
Contact details
Division of Gastroenterology
C Floor South Block
University Hospital
Nottingham
NG7 2UH
United Kingdom
+44 (0)115 924 9924 (41352)
robin.spiller@nottingham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0192080637
Study information
Scientific title
Acronym
Study hypothesis
Can treatment with bismuth salts improve symptoms in subjects with functional diarrhoea and enteroendocrine cell hyperplasia?
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: 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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
13/09/1999
Overall trial end date
30/11/2004
Reason abandoned
Poor recruitment and lack of staff
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
15 patients with functional diarrhoea, 15 control patients, total=30.
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
13/09/1999
Recruitment end date
30/11/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Division of Gastroenterology
Nottingham
NG7 2UH
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Queen's Medical Centre University Hospital 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