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
Secondary identifying numbers G0001078
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

Study website

Contact information

Dr Brendan Delaney
Scientific

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

b.c.delaney@bham.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeNot Specified
Scientific title
Study acronymCUBE
Study objectives1. 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) studiedDyspepsia in primary care
InterventionAll 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)omeprazole, clarithromycin, metronidazole
Primary outcome measure1. 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).
Secondary outcome measures1. 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
Overall study start date01/03/2002
Completion date28/02/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participantsTarget number: 2000; Number actually enrolled: 699
Key inclusion criteriaAll patients age 18-65 years consulting GP with dyspepsia (either with a new episode or for follow up).
Key exclusion criteria1. 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 enrolment01/03/2002
Date of final enrolment28/02/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Primary Care & General Practice
Birmingham
B15 2TT
United Kingdom

Sponsor information

University of Birmingham (UK)
University/education

Edgbaston
Birmingham
B15 2TT
England
United Kingdom

http://www.bham.ac.uk
ROR logo https://ror.org/03angcq70

Funders

Funder type

Research council

Medical Research Council (UK)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

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

Study outputs

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