A multicentre randomised controlled trial of C13-Urea Breath testing and Helicobacter pylori eradication for dyspepsia in primary care

ISRCTN	ISRCTN87644265
DOI	https://doi.org/10.1186/ISRCTN87644265
Protocol serial number	G0001078
Sponsor	University of Birmingham (UK)
Funder	Medical Research Council (UK)

Submission date: 02/05/2001
Registration date: 02/05/2001
Last edited: 31/03/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Brendan Delaney
Scientific

Department of Primary Care & General Practice
The Medical School
Edgbaston
Birmingham
B15 2TT
United Kingdom

Email	b.c.delaney@bham.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	CUBE
Study objectives	1. To determine the cost-effectiveness of an H. pylori 'test and trust' strategy compared with initial acid suppression for the initial management of dyspensia in primary care 2. To determine the influence of selected patients on the basis of predominant heartburn or epigastic pain 3. To determine the performance of the H. pylori stool antigen (HpSA) test for H. pylori compared with a C13 Urea breath test for confirming H. pylori eradication in primary care Please note that the target number of participants was added as of 06/03/2008.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Dyspepsia in primary care
Intervention	All patients - will receive omeprazole 20mg once daily. Study Group - C13 Urea breath test for H. pylori, using a test kit performed by the practice nurse. Patients testing positive will be offered H. pylori eradication with clarithromycin 250 mg twice daily and metronidazole 400 mg twice daily in addition to omeprazole. Patients testing negative will continue PPI (omeprazole). Control Group - Patients will continue 4/52 PPI (omeprazole). After four weeks patient management will be at the discretion of the general practitioner (GP). Patients receiving H. pylori eradication will be contacted by research staff and asked to attend for a follow-up breath test and produce a stool sample (for the stool antigen test) nine weeks after entry. Follow-up will be by postal questionnaire at 12 weeks, interview at one year and a GP notes review (conducted by research staff).
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	omeprazole, clarithromycin, metronidazole
Primary outcome measure(s)	1. Effects measured as absolute risk reduction for dyspeptic symptoms measured by the Short Form Leeds Dyspepsia score, a validated community-based measure that also includes a question on 'predominant symptoms'. 2. Health service related dyspepsia costs as determined by application of national reference costs to individual units of resource consumption (prescribing, consultations, interventions and investigations).
Key secondary outcome measure(s)	1. Quality of life using Euro-QoL instrument (EQ-5D). 2. Patient satisfaction using the consultations Satisfaction Score (subscales one and two, general and professional care) 3. Performance of HpSA test
Completion date	28/02/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	2000
Key inclusion criteria	All patients age 18-65 years consulting GP with dyspepsia (either with a new episode or for follow up).
Key exclusion criteria	1. Knowledge of previous test for H. pylori. 2. Patients who have a history suggestive of gastric cancer.i.e. dysphagia, weight loss, haematemesis or malaena, first-degree relative with gastric cancer. 3. Patient age 55-65 with continuous as opposed to episodic epigastric pain or a total history of any dyspeptic symptoms of less than a year at presentation (in accord with the National Health Service two week suspected cancer referral guidelines). 4. Knowledge of endoscopically proven peptic ulcer disease or severe oesophagitis (who should all receive either eradication therapy (ulcer) or proton pump inhibitor (oesophagitis) 5. Pregnant women 6. Patients who are unable to give informed consent 7. Patients taking regular non-steroidal anti-inflammatory drugs (who might have NSAID induced ulcers),or having started aspirin 75 - 150 mg in the past three months 8. Patients allergic to study drugs 9. Residents of USA or Canada
Date of first enrolment	01/03/2002
Date of final enrolment	28/02/2006

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Department of Primary Care & General Practice

Birmingham
B15 2TT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	22/03/2008		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes