Evaluation of H. pylori infection in aspirin users - pilot study

Helicobacter pylori Eradication vs Aspirin Toxicity pilot study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10740230

Enrollment

905

Registered

2008-03-27

Start date

2008-02-01

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Ulcer bleeding Digestive System

Interventions

This trial has two parts: Part 1: Interventional study. This study will establish the H. pylori infection rates and success of eradication therapy. GPs will screen their patient records for potent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male and female patients aged 45 years of age or older 2. Patients who have given written informed consent 3. Patients taking aspirin (less than or equal to 300 mg daily) NB: Patients who have previously been tested for H. pylori and/or had previous eradication therapy will not be excluded.

Exclusion criteria

Exclusion criteria: 1. Patients currently taking anti-ulcer therapy (H2-receptor antagonists i.e. cimetidine, famotidine, nizatidine or ranitidine and Proton Pump Inhibitors [PPIs] i.e. esomeprazole, lansoprazole, omeprazole, pantoprazole or rabeprazole sodium) 2. Patients currently taking non-selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (aceclofenac, acemetacin, azapropazone, dexibuprofen, dexketoprofen, diclofenac sodium, diflunisal, fenbufen, fenoprofen, flurbiprofen, ibuprofen, indometacin, ketoprofen, mefenamic acid, meloxicam, nabumetone, naproxen, piroxicam, sulindac, tenoxicam, or tiaprofenic acid) 3. Patients who are terminally ill 4. Patients who are allergic to any of the eradication treatment drugs 5. Patients who are currently being treated with an antibacterial or have had antibacterial treatment within the last 4 weeks 6. Patients who have had treatment with a PPI (listed above) within the last 2 weeks. 7. Women who are pregnant or breast feeding

Design outcomes

Primary

Measure	Time frame
1. Rate of aspirin use (results of Part 2 Observational study) 2. Rate of ulcer bleeding in patients using aspirin (results of Part 2 Observational study) 3. Level of H. pylori infection and subsequent eradication rates in aspirin patients at 6-8 weeks after the eradication therapy 4. Level of interest from GPs and patients for a randomised study and their preferred enrolment site	—

Secondary

Measure	Time frame
No secondary outcome measures	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026