Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LIP/H2B/001
Study information
Scientific title
Acronym
HEALTH
Study hypothesis
To determine the impact of a community-based Helicobacter pylori screening and eradication programme on the incidence of dyspepsia, resource use and Quality of Life (QoL), including a cost-consequences analysis.
Ethics approval
Gained ethics approval from Frenchay Hospital LREC (reference number: 95/83 20/01/1996).
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Dyspepsia
Intervention
Subjects were screened for H. pylori. Those who were positive were randomised between active eradication therapy or a placebo. Subjects were not randomised if they were found to be uninfected with H. pylori.
Intervention type
Drug
Phase
Not Specified
Drug names
Helicobacter pylori
Primary outcome measures
Dyspepsia resolution at two years after randomisation.
Secondary outcome measures
1. Reduction in health service utilisation
2. Quality of life
Overall trial start date
01/05/1996
Overall trial end date
01/05/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 20 to 59 years, male and female
2. Able to give written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1550
Participant exclusion criteria
Any persons with the following conditions: pregnancy, breast feeding, severe renal impairment, adverse reaction to macrolide antibiotics, concurrent medication with wafarin, theophyllin, digoxin, terfendine, carbemazepine, ergot derivatives, bismuth compounds, acute porphyria.
Recruitment start date
01/05/1996
Recruitment end date
01/05/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Bristol
Bristol
BS8 2PR
United Kingdom
Sponsor information
Organisation
NHS (South and West) (UK)
Sponsor details
Westward House
Lime Kiln Close
Stoke Gifford
Bristol
BS12 6SR
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive (south and west)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Glaxo Wellcome 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. 2004 results: http://www.ncbi.nlm.nih.gov/pubmed/15126313
2. 2006 results: http://www.ncbi.nlm.nih.gov/pubmed/16428249
3. 2008 results: http://www.ncbi.nlm.nih.gov/pubmed/18412958
Publication citations
-
Results
Harvey RF, Lane JA, Murray LJ, Harvey IM, Donovan JL, Nair P, , Randomised controlled trial of effects of Helicobacter pylori infection and its eradication on heartburn and gastro-oesophageal reflux: Bristol helicobacter project., BMJ, 2004, 328, 7453, 1417, doi: 10.1136/bmj.38082.626725.EE.
-
Results
Murray LJ, McCarron P, McCorry RB, Anderson LA, Lane AJ, Johnston BT, Smith GD, Harvey RF, Inverse association between gastroesophageal reflux and blood pressure: results of a large community based study., BMC Gastroenterol, 2008, 8, 10, doi: 10.1186/1471-230X-8-10.
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Lane JA, Murray LJ, Noble S, Egger M, Harvey IM, Donovan JL, Nair P, Harvey RF, Impact of Helicobacter pylori eradication on dyspepsia, health resource use, and quality of life in the Bristol helicobacter project: randomised controlled trial., BMJ, 2006, 332, 7535, 199-204, doi: 10.1136/bmj.38702.662546.55.