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
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

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 information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesCan 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) studiedDigestive System: Diarrhoea
Intervention1. Bismuth treatment group
2. Placebo

Added July 2008: trial never started, due to poor recruitment and lack of resources.
Intervention typeOther
Primary outcome measureSymptom Score (Bowel frequency/day, days of pain/week, presence of urgency, stool consistency), enteroendocrine cell and intraepithelial lymphocyte count on rectal biopsy.
Secondary outcome measuresNot provided at time of registration
Overall study start date13/09/1999
Completion date30/11/2004
Reason abandoned (if study stopped)Poor recruitment and lack of staff

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit80 Years
SexBoth
Target number of participants15 patients with functional diarrhoea, 15 control patients, total=30.
Key inclusion criteria1. Age range of subjects: patients = 18-80 years; control patients 18-80 years
2. Sex of subjects: patients = both; control patients = both
Key exclusion criteriaNot provided at time of registration
Date of first enrolment13/09/1999
Date of final enrolment30/11/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Division of Gastroenterology
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

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

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan