Condition category
Digestive System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
10/11/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Paul Moayyedi

ORCID ID

Contact details

Gastroenterology Unit
City Hospital
Dudley Road
Birmingham
B18 7QH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

00001 RSU447971

Study information

Scientific title

Acronym

Study hypothesis

Helicobacter pylori is responsible for 95% of duodenal ulcers and most gastric ulcers. It may be responsible for some functional dyspepsia and may be a major factor in the aetiology of gastric cancer, the fourth commonest cause of death from malignancy in the UK. Approximately one person in forty of the UK population dies from a H. pylori associated disease. Successful eradication from the community should prevent duodenal ulcer, gastric ulcer and possibly gastric cancer. An average FHSA spends £4,000,000 per annum on acid reducing drugs. The Leeds FHSA expenditure is £5,000,000 per annum. The investigation of dyspepsia is also costly. The General Infirmary at Leeds serving a population of 400,000 spends £800,000 per annum on endoscopy and £90,000 per annum on barium meals. 10% of the population consult their general practitioner for dyspepsia every six months. Patients with dyspepsia have 2.6 times as many sick leave days as the background population matched for age, sex and occupational status. Primary prevention could lead to saving in drug expenditure, general practice consultations and hospital investigation. It should lead to reduction in the costs of sick pay, invalidity benefit and should reduce time lost from work.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Other

Patient information sheet

Condition

Digestive system diseases: Peptic ulcer disease

Intervention

Treatment for H. pylori versus placebo

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Absence of dyspepsia at two years
2. NHS dyspepsia costs for two years after the intervention

Secondary outcome measures

1. Dyspepsia subgroups
2. Quality of life
3. H. pylori eradication rates
4. Adverse events

Overall trial start date

07/01/1994

Overall trial end date

30/06/1998

Reason abandoned

Eligibility

Participant inclusion criteria

Patients aged 50-59 years from selected General Practice (GP) surgeries (including asymptomatic volunteers as well as patients with dyspepsia)

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

1. Severe mental illness
2. Severe medical illness that would make the subject unable to survive for two years
3. Allergy to proton inhibitors, clarythromycin or metronizadole
4. Unwillingness to abstain from alcohol whilst taking antibiotics
5. Pregnancy
6. Concomitant prescription of cisapride, warfarin, antihistamines or theophyllines

Recruitment start date

07/01/1994

Recruitment end date

30/06/1998

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Gastroenterology Unit
Birmingham
B18 7QH
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive Northern and Yorkshire (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2000 results in http://www.ncbi.nlm.nih.gov/pubmed/10905240
2. 2005 10 year follow-up results in http://www.ncbi.nlm.nih.gov/pubmed/16344059

Publication citations

  1. Results

    Moayyedi P, Feltbower R, Brown J, Mason S, Mason J, Nathan J, Richards ID, Dowell AC, Axon AT, Effect of population screening and treatment for Helicobacter pylori on dyspepsia and quality of life in the community: a randomised controlled trial. Leeds HELP Study Group., Lancet, 2000, 355, 9216, 1665-1669.

  2. Ford AC, Forman D, Bailey AG, Axon AT, Moayyedi P, A community screening program for Helicobacter pylori saves money: 10-year follow-up of a randomized controlled trial., Gastroenterology, 2005, 129, 6, 1910-1917, doi: 10.1053/j.gastro.2005.09.016.

Additional files

Editorial Notes