A randomised controlled trial of bismuth in the treatment of functional diarrhoea

ISRCTN	ISRCTN86357226
DOI	https://doi.org/10.1186/ISRCTN86357226
Secondary identifying numbers	N0192080637

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

Prof Robin Spiller
Scientific

Division of Gastroenterology
C Floor South Block
University Hospital
Nottingham
NG7 2UH
United Kingdom

Phone	+44 (0)115 924 9924 (41352)
Email	robin.spiller@nottingham.ac.uk

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	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

Participant type(s)	Patient
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

Division of Gastroenterology

Nottingham
NG7 2UH
United Kingdom

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Government

Queen's Medical Centre University Hospital NHS Trust (UK)

No information available

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