Condition category
Digestive System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
27/09/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes