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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
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
-
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.
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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.