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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN87644265

Enrollment

2000

Registered

2001-05-02

Start date

2002-03-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspepsia in primary care Digestive System Dyspepsia

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

—

Secondary

Measure	Time frame
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	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 5, 2026