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

Completed

Conditions: Dyspepsia in primary care
Digestive System
Dyspepsia

Registration Number: ISRCTN87644265

Lead Sponsor: niversity of Birmingham (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 2000

Inclusion Criteria

All patients age 18-65 years consulting GP with dyspepsia (either with a new episode or for follow up).

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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'.<br>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 Measures

Name	Time	Method
1. Quality of life using Euro-QoL instrument (EQ-5D).<br>2. Patient satisfaction using the consultations Satisfaction Score (subscales one and two, general and professional care)<br>3. Performance of HpSA test